<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03026088</url>
  </required_header>
  <id_info>
    <org_study_id>MS200006-0039</org_study_id>
    <nct_id>NCT03026088</nct_id>
  </id_info>
  <brief_title>Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants</brief_title>
  <acronym>Biso-CHF</acronym>
  <official_title>A Single-arm, Interventional, Multi-center, Pilot Study to Evaluate the Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Patients With NYHA Class II - IV (Biso-CHF Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck KGaA, Darmstadt, Germany</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Serono Co., Ltd., China</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck KGaA, Darmstadt, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Limited beta-blocker naive participants among newly diagnosed heart failure participants, which&#xD;
    led barrier to the recruitments.&#xD;
  </why_stopped>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">December 26, 2018</completion_date>
  <primary_completion_date type="Actual">December 26, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Resting Heart Rate at Week 6</measure>
    <time_frame>Baseline, Week 6</time_frame>
    <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Resting Heart Rate at Week 14</measure>
    <time_frame>Baseline, Week 14</time_frame>
    <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Resting Heart Rate at Week 26</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Resting Heart Rate at Week 3, 10 and 18</measure>
    <time_frame>Baseline, Week 3, 10 and 18</time_frame>
    <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26</measure>
    <time_frame>Baseline, Week 14 and 26</time_frame>
    <description>LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26</measure>
    <time_frame>Baseline, Week 14 and 26</time_frame>
    <description>Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26</measure>
    <time_frame>Baseline, Week 14 and 26</time_frame>
    <description>Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26</measure>
    <time_frame>Baseline, Week 14 and 26</time_frame>
    <description>Interventricular septal thickness was measured by Ultrasound cardiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26</measure>
    <time_frame>Baseline, Week 14 and Week 26</time_frame>
    <description>Early to late ratio was measured by ultrasound cardiogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure</measure>
    <time_frame>Screening (Week -2) up to Week 26</time_frame>
    <description>Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With New York Heart Association (NYHA) Class</measure>
    <time_frame>Baseline, Week 26</time_frame>
    <description>The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm</measure>
    <time_frame>Baseline up to Week 26</time_frame>
    <description>Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment</measure>
    <time_frame>Baseline, end of treatment (Week 26)</time_frame>
    <description>MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment</measure>
    <time_frame>Baseline, end of treatment (Week 26)</time_frame>
    <description>Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-Minute Walk Test</measure>
    <time_frame>Baseline and End of treatment (Week 26)</time_frame>
    <description>6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP)</measure>
    <time_frame>Baseline up to End of treatment (Week 26)</time_frame>
    <description>Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean 24 Hour, Day Time and Night Time Heart Rate</measure>
    <time_frame>Baseline, week 6, 14 and end of treatment (Week 26)</time_frame>
    <description>Holter monitor was used to measure heart rate (24 hour, day time, night time).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Arrhythmia</measure>
    <time_frame>Baseline up to end of treatment (Week 26)</time_frame>
    <description>Holter monitor was used to diagnose arrhythmia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm</measure>
    <time_frame>Baseline, week 6, 14 and end of treatment (Week 26)</time_frame>
    <description>Holter monitor was used to measure heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR)</measure>
    <time_frame>Up to Week 26</time_frame>
    <description>MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (&lt;) 80% or greater than (&gt;)100% is defined as insufficient compliance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure</measure>
    <time_frame>Up to Week 26</time_frame>
    <description>Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Bisoprolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisoprolol</intervention_name>
    <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
    <arm_group_label>Bisoprolol</arm_group_label>
    <other_name>Brand name: Concor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 year, male or female.&#xD;
&#xD;
          -  Chronic Heart failure subjects with medical history of cardiac disease or other&#xD;
             related cardiovascular disease.&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) less than or equal to (=&lt;) 40 percent (%).&#xD;
&#xD;
          -  New York Heart Association (NYHA) class of II - IV&#xD;
&#xD;
          -  NYHA II ： Slight limitation of physical activity. Comfortable at rest, but ordinary&#xD;
             physical activity results in undue breathlessness, fatigue or palpitation.&#xD;
&#xD;
          -  NYHA III：Marked limitation of physical activity. Comfortable at rest, but less than&#xD;
             ordinary activity causes undue breathlessness, fatigue or palpitation.&#xD;
&#xD;
          -  NYHA IV：Unable to carry on any physical activity without discomfort. Symptoms at rest&#xD;
             can be present. If any physical activity is undertaken, discomfort increased.&#xD;
&#xD;
          -  Signed Informed Consent Form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute coronary syndrome (ACS) within 3 months.&#xD;
&#xD;
          -  Under beta-blocker treatment for the last 2 weeks.&#xD;
&#xD;
          -  Under other medicine treatment which may affect heart rate, like Non-dihydropyridine&#xD;
             calcium channel blockers (NDHP-CCBs) or ivabradine for the last 2 weeks; Under Digoxin&#xD;
             treatment [more than (&gt;) 0.125 milligram (mg)].&#xD;
&#xD;
          -  Uncontrolled Diabetes [hemoglobin A1c, (HbA1c) &gt;7.5%].&#xD;
&#xD;
          -  Severe or uncontrolled hypertension [resting Systolic Blood Pressure (SBP) &gt;180&#xD;
             millimeters of mercury (mmHg), or resting Diastolic Blood Pressure (DBP) &gt;110mmHg at&#xD;
             screening period].&#xD;
&#xD;
          -  Severe hypotension [resting SBP less than (&lt;) 90mmHg, or resting DBP&lt;50mmHg].&#xD;
&#xD;
          -  Resting heart rate &lt;60 beat per minute (bpm).&#xD;
&#xD;
          -  Any contradiction to Bisoprolol according to label, including:&#xD;
&#xD;
          -  Acute heart failure or during episodes of heart failure decompensation requiring&#xD;
             intravenous inotropic therapy.&#xD;
&#xD;
          -  Cardiogenic shock.&#xD;
&#xD;
          -  Atrioventricular block of second or third degree (without a pacemaker).&#xD;
&#xD;
          -  Sick sinus syndrome.&#xD;
&#xD;
          -  Sinoatrial block.&#xD;
&#xD;
          -  Slowed heart rate, causing symptoms (symptomatic bradycardia),&#xD;
&#xD;
          -  Decreased blood pressure, causing symptoms (symptomatic hypotension),&#xD;
&#xD;
          -  Severe bronchial asthma or severe chronic obstructive pulmonary disease.&#xD;
&#xD;
          -  Sever forms of peripheral arterial occlusive disease and Raynaud's syndrome.&#xD;
&#xD;
          -  Untreated phaeochromocytoma.&#xD;
&#xD;
          -  Metabolic acidosis.&#xD;
&#xD;
          -  Hypersensitivity to bisoprolol or to any of the excipients.&#xD;
&#xD;
          -  Severe Arrhythmia including atrial fibrillation, atrial flutter, ventricular&#xD;
             fibrillation, ventricular flutter or ventricular tachycardia.&#xD;
&#xD;
          -  Significant valvular heart disease, congenital heart disease, pulmonary heart disease&#xD;
             or perinatal heart disease.&#xD;
&#xD;
          -  Acute pulmonary edema.&#xD;
&#xD;
          -  Severe hepatic dysfunction, defined as:&#xD;
&#xD;
          -  Serum Alanine Aminotransferase (ALT) &gt; triple the upper limit of the normal range;&#xD;
             and/or&#xD;
&#xD;
          -  Serum Aspartate Aminotransferase (AST) &gt; triple the upper limit of the normal value&#xD;
             range and/or&#xD;
&#xD;
          -  Severe renal dysfunction, defined as:&#xD;
&#xD;
          -  Serum creatinine &gt; twice the upper limit of the normal range&#xD;
&#xD;
          -  Chronic Kidney Disease (glomerular filtration rate &lt;45 Milliliter per minute).&#xD;
&#xD;
          -  Hyperthyroidism or hypothyroidism.&#xD;
&#xD;
          -  Severe infectious disease, example (eg) Human Immunodeficiency Virus positive or&#xD;
             active tuberculosis.&#xD;
&#xD;
          -  Severe autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.&#xD;
&#xD;
          -  Severe respiratory, digestive, hematological disease (including Anemia of Hb &lt; 100&#xD;
             gram per litre) or tumor.&#xD;
&#xD;
          -  Known to be hypersensitivity to Bisoprolol, or any of the excipient.&#xD;
&#xD;
          -  Substance or alcohol abuse.&#xD;
&#xD;
          -  Received heart transplantation or pacemaker implantation; revascularization treatment&#xD;
             within 3 months; or plan to receive above treatment in 6 months.&#xD;
&#xD;
          -  Currently undertaking other treatment that may affect the safety and/or efficacy&#xD;
             evaluation, e.g. beta receptors agonists, et cetera.&#xD;
&#xD;
          -  No legal ability or legal ability is limited.&#xD;
&#xD;
          -  Subjects unlikely to cooperate in the study or with inability or unwillingness to give&#xD;
             informed consent.&#xD;
&#xD;
          -  Child-bearing period women without effective contraceptive measures, pregnancy and&#xD;
             lactation.&#xD;
&#xD;
          -  Participation in another clinical trial within the past 90 days.&#xD;
&#xD;
          -  Other significant condition that in the Investigator's opinion would exclude the&#xD;
             subject from the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Responsible</last_name>
    <role>Study Director</role>
    <affiliation>Merck Serono Co., Ltd., China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fuwai Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>December 10, 2019</results_first_submitted>
  <results_first_submitted_qc>January 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2020</results_first_posted>
  <last_update_submitted>January 20, 2020</last_update_submitted>
  <last_update_submitted_qc>January 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Heart Failure</keyword>
  <keyword>Bisoprolol</keyword>
  <keyword>Heart rate control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bisoprolol</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03026088/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bisoprolol</title>
          <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study termination</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bisoprolol</title>
          <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.37" spread="13.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Resting Heart Rate at Week 6</title>
        <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
        <time_frame>Baseline, Week 6</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Resting Heart Rate at Week 6</title>
          <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Resting Heart Rate at Week 3, 10 and 18</title>
        <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
        <time_frame>Baseline, Week 3, 10 and 18</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Resting Heart Rate at Week 3, 10 and 18</title>
          <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26</title>
        <description>LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF.</description>
        <time_frame>Baseline, Week 14 and 26</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26</title>
          <description>LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26</title>
        <description>Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram.</description>
        <time_frame>Baseline, Week 14 and 26</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26</title>
          <description>Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26</title>
        <description>Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram.</description>
        <time_frame>Baseline, Week 14 and 26</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26</title>
          <description>Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26</title>
        <description>Interventricular septal thickness was measured by Ultrasound cardiogram.</description>
        <time_frame>Baseline, Week 14 and 26</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26</title>
          <description>Interventricular septal thickness was measured by Ultrasound cardiogram.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26</title>
        <description>Early to late ratio was measured by ultrasound cardiogram.</description>
        <time_frame>Baseline, Week 14 and Week 26</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26</title>
          <description>Early to late ratio was measured by ultrasound cardiogram.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure</title>
        <description>Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator.</description>
        <time_frame>Screening (Week -2) up to Week 26</time_frame>
        <population>The safety population included all participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure</title>
          <description>Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator.</description>
          <population>The safety population included all participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With New York Heart Association (NYHA) Class</title>
        <description>The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>The safety population included all participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With New York Heart Association (NYHA) Class</title>
          <description>The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased.</description>
          <population>The safety population included all participants who received at least 1 dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: NYHA class II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: NYHA class III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: NYHA class IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26: NYHA class II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26: NYHA class III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26: NYHA class IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26: Not evaluated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm</title>
        <description>Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate.</description>
        <time_frame>Baseline up to Week 26</time_frame>
        <population>The safety population included all subjects who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm</title>
          <description>Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate.</description>
          <population>The safety population included all subjects who received at least one dose of study treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment</title>
        <description>MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life.</description>
        <time_frame>Baseline, end of treatment (Week 26)</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment</title>
          <description>MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment</title>
        <description>Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
        <time_frame>Baseline, end of treatment (Week 26)</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment</title>
          <description>Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6-Minute Walk Test</title>
        <description>6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.</description>
        <time_frame>Baseline and End of treatment (Week 26)</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>6-Minute Walk Test</title>
          <description>6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP)</title>
        <description>Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value).</description>
        <time_frame>Baseline up to End of treatment (Week 26)</time_frame>
        <population>The safety population included all participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP)</title>
          <description>Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value).</description>
          <population>The safety population included all participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean 24 Hour, Day Time and Night Time Heart Rate</title>
        <description>Holter monitor was used to measure heart rate (24 hour, day time, night time).</description>
        <time_frame>Baseline, week 6, 14 and end of treatment (Week 26)</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean 24 Hour, Day Time and Night Time Heart Rate</title>
          <description>Holter monitor was used to measure heart rate (24 hour, day time, night time).</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Arrhythmia</title>
        <description>Holter monitor was used to diagnose arrhythmia.</description>
        <time_frame>Baseline up to end of treatment (Week 26)</time_frame>
        <population>The safety population included all participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Arrhythmia</title>
          <description>Holter monitor was used to diagnose arrhythmia.</description>
          <population>The safety population included all participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm</title>
        <description>Holter monitor was used to measure heart rate.</description>
        <time_frame>Baseline, week 6, 14 and end of treatment (Week 26)</time_frame>
        <population>The safety population included all participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm</title>
          <description>Holter monitor was used to measure heart rate.</description>
          <population>The safety population included all participants who received at least 1 dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR)</title>
        <description>MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (&lt;) 80% or greater than (&gt;)100% is defined as insufficient compliance.</description>
        <time_frame>Up to Week 26</time_frame>
        <population>The safety population included all participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR)</title>
          <description>MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (&lt;) 80% or greater than (&gt;)100% is defined as insufficient compliance.</description>
          <population>The safety population included all participants who received at least 1 dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MPR: Good Compliance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MPR: Insufficient compliance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not evaluated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure</title>
        <description>Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported.</description>
        <time_frame>Up to Week 26</time_frame>
        <population>The safety population included all participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure</title>
          <description>Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported.</description>
          <population>The safety population included all participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-cause mortality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Re-admission due to heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Resting Heart Rate at Week 14</title>
        <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
        <time_frame>Baseline, Week 14</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Resting Heart Rate at Week 14</title>
          <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Resting Heart Rate at Week 26</title>
        <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
        <time_frame>Baseline, Week 26</time_frame>
        <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
        <group_list>
          <group group_id="O1">
            <title>Bisoprolol</title>
            <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Resting Heart Rate at Week 26</title>
          <description>Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.</description>
          <population>Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 26</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bisoprolol</title>
          <description>Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea at rest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA version 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinoatrial block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection 3 (15.0)</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Communication Center</name_or_title>
      <organization>Merck KGaA, Darmstadt, Germany</organization>
      <phone>+49-6151-72-5200</phone>
      <email>service@emdgroup.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03026088
org study id: MS200006-0039
nct id: NCT03026088
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-arm, open label, interventional, multi-center, phase 4 pilot study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Resting Heart Rate at Week 6
time frame: Baseline, Week 6
description: Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
measure: Change From Baseline in Resting Heart Rate at Week 14
time frame: Baseline, Week 14
description: Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
measure: Change From Baseline in Resting Heart Rate at Week 26
time frame: Baseline, Week 26
description: Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
measure: Change From Baseline in Resting Heart Rate at Week 3, 10 and 18
time frame: Baseline, Week 3, 10 and 18
description: Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.
measure: Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26
time frame: Baseline, Week 14 and 26
description: LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF.
measure: Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26
time frame: Baseline, Week 14 and 26
description: Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram.
measure: Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26
time frame: Baseline, Week 14 and 26
description: Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram.
measure: Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26
time frame: Baseline, Week 14 and 26
description: Interventricular septal thickness was measured by Ultrasound cardiogram.
measure: Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26
time frame: Baseline, Week 14 and Week 26
description: Early to late ratio was measured by ultrasound cardiogram.
measure: Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure
time frame: Screening (Week -2) up to Week 26
description: Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator.
measure: Number of Participants With New York Heart Association (NYHA) Class
time frame: Baseline, Week 26
description: The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased.
measure: Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm
time frame: Baseline up to Week 26
description: Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate.
measure: Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment
time frame: Baseline, end of treatment (Week 26)
description: MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life.
measure: Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment
time frame: Baseline, end of treatment (Week 26)
description: Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
measure: 6-Minute Walk Test
time frame: Baseline and End of treatment (Week 26)
description: 6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.
measure: Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP)
time frame: Baseline up to End of treatment (Week 26)
description: Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value).
measure: Mean 24 Hour, Day Time and Night Time Heart Rate
time frame: Baseline, week 6, 14 and end of treatment (Week 26)
description: Holter monitor was used to measure heart rate (24 hour, day time, night time).
measure: Number of Participants With Arrhythmia
time frame: Baseline up to end of treatment (Week 26)
description: Holter monitor was used to diagnose arrhythmia.
measure: Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm
time frame: Baseline, week 6, 14 and end of treatment (Week 26)
description: Holter monitor was used to measure heart rate.
measure: Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR)
time frame: Up to Week 26
description: MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (<) 80% or greater than (>)100% is defined as insufficient compliance.
measure: Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure
time frame: Up to Week 26
description: Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported.
arm group label: Bisoprolol
arm group type: Experimental
intervention type: Drug
intervention name: Bisoprolol
description: Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
arm group label: Bisoprolol
other name: Brand name: Concor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Medical Responsible
role: Study Director
affiliation: Merck Serono Co., Ltd., China
facility: 
country: China
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Bisoprolol
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants.
point of contact: 