<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/NCT04471610</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01030</org_study_id>
    <nct_id>NCT04471610</nct_id>
  </id_info>
  <brief_title>Point Of Care With Serial NT-proBNP Measurement in Patients With Acute Decompensation of Heart Failure</brief_title>
  <official_title>Point Of Care With Serial NT-proBNP Measurement in Patients With Acute Decompensation of Heart Failure as a Therapy-monitoring During Hospitalization: A Prospective, Unblinded, Randomized, Controlled Pilot Trial - The POC-HF Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Jörg Leuppi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hosptal, Baselland</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>
      The goal of this study is to explore whether the availability of serial NT-proBNP&#xD;
      measurements together with safety parameters such as electrolytes and creatinine may&#xD;
      influence treatment decision in patients with acute decompensated heart failure (ADHF)&#xD;
      leading to more rapid and faster dose increase of prognostic therapies and earlier hospital&#xD;
      discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a prospective, unblinded, single center, 2-arm randomized controlled&#xD;
      pilot trial. In the intervention arm serial measurement of NT-proBNP will be made available&#xD;
      to the treating physician. A control group continuing to undergo care according to the 2016&#xD;
      ESC Guidelines will serve as comparator. Changes in NT-proBNP levels, safety laboratory&#xD;
      parameters such as sodium, potassium, creatinine, Heart failure (HF) medication, vital signs,&#xD;
      body weight and BMI, Quality of Life (QoL), length of hospital stay, New York Heart&#xD;
      Association (NYHA) functional class, adverse events, transfer to the Intensive Care Unit and&#xD;
      mortality will be recorded in patients with ADHF.&#xD;
&#xD;
      The Kantonsspital Baselland (KSBL) Liestal will be the only study center. All members of the&#xD;
      study group will the thoroughly instructed regarding study procedures. Inclusion visits will&#xD;
      be conducted only by a member of the study group. All Patients with ADHF on the medical ward&#xD;
      of the KSBL Liestal will be provided an information sheet regarding goals and procedures of&#xD;
      the study and the informed consent. Inclusion criteria will be checked after admission.&#xD;
      Patients not matching the inclusion criteria at the screening visit cannot participate in&#xD;
      this study. Patients will be provided sufficient time for their decision. The investigators&#xD;
      communicate clearly that participation in the study is absolutely voluntary and refusal of&#xD;
      participation has no influence on treatment during hospitalization.&#xD;
&#xD;
      In order to minimize bias that may be introduced by even minor differences in executing and&#xD;
      interpreting technical exams, all study related measurements and procedures will be performed&#xD;
      in a centralized manner at the KSBL Liestal.&#xD;
&#xD;
      Patients will be included only after approval of informed consent. Randomization is performed&#xD;
      using 50 closed envelopes containing a paper shit with either the letter A or B. In total&#xD;
      there are 25 A's and 25 B's. The letter A stands for the control group and the letter B for&#xD;
      the intervention group. These envelopes are mixed initially, numbered for order purposes and&#xD;
      the order maintained throughout the study. The name of the patient will be written down on&#xD;
      the envelope. Then it will be open and the patient will be allocated to the study group&#xD;
      depending on the letter in the envelope. All patients will undergo an inclusion and discharge&#xD;
      visit. General demographic data, including age, gender, nationality, smoking status, alcohol&#xD;
      consumption, current profession, exercise behavior, allergies, medication, HF history and&#xD;
      comorbidities will be recorded. Assessment of vital signs and body weight will be performed&#xD;
      together with an electrocardiogram, several laboratory tests (NT-proBNP, potassium, sodium&#xD;
      and creatinine). In addition, questionnaires concerning QoL (SF-12, KCCQ, MLWHFQ) will be&#xD;
      filled in by the participants. Women who can get pregnant (not yet in menopause and last&#xD;
      menstrual period less than 12 months, not surgically sterilized, ovaries and/or uterus not&#xD;
      removed) will have to undergo a pregnancy test prior to inclusion into the study.&#xD;
&#xD;
      Patients allocated to the intervention group (POC-available group) will undergo serial&#xD;
      measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day. The&#xD;
      investigators have chosen this time-lag because an earlier time point would not show the&#xD;
      change of the security parameter creatinine due to longer half-life-time. For this test,&#xD;
      blood is collected from the patients. These samplings will be done in the morning together&#xD;
      with the regularly blood collection through the attending nurse according to the established&#xD;
      procedure of the KSBL Liestal in the morning. 10ml blood will be collected for this study&#xD;
      during each blood sample with a standard Lithium-blood-collection tube. Members of the study&#xD;
      team will collect the blood samples and analyses them on the study devices. The result of the&#xD;
      test will be provided directly to the responsible physician of the medical department at the&#xD;
      KSBL Liestal. Treatment changes are at the discretion of the responsible physician. The&#xD;
      physician will be alerted by a phone call of a study member if the NT-proBNP hasn't decreased&#xD;
      by 10% or more between two measurements. But no specific recommendations with regards to&#xD;
      therapy will be provided by the investigator or his team. However, diagnostic and therapeutic&#xD;
      decisions will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF&#xD;
      as established at the KSBL Liestal.&#xD;
&#xD;
      Patients allocated to the control group will undergo the measurements at inclusion and&#xD;
      discharge visit. The control group conduces to compare the NT-proBNP and HF medication&#xD;
      changes under therapy monitoring with serial NT-proBNP measurements to the NT-proBNP and HF&#xD;
      medication changes with sign and symptom guided HF therapy. As in the intervention group,&#xD;
      diagnostic and therapeutic decisions in the control group will be based on the current 2016&#xD;
      ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal. At&#xD;
      discharge, the same measurements as at the inclusion visit will be repeated in all patients&#xD;
      to monitor the effects associated with the participation in this trial.&#xD;
&#xD;
      Total study duration will cover a period of approximately 3 years. Patients will be screened&#xD;
      until a total of 25 patients are included per study group.&#xD;
&#xD;
      Overall, 50 patients are planned to be recruited. Recruitment is estimated to start in&#xD;
      September 2017 and end at the latest in March 2020 after discharge of the last hospitalized&#xD;
      patient included in the study. Data collection of the study is expected to be completed by&#xD;
      May 2020 and data analysis by December 2020.&#xD;
&#xD;
      The expected duration of the study for each patient will be defined by the time period from&#xD;
      inclusion to discharge and is expected to be in the range of 8-12 days (=average time for HF&#xD;
      hospitalization of our institution).&#xD;
&#xD;
      As an university institution, the KSBL Liestal mandates its physician and nursing staff to&#xD;
      provide evidence-based medical care and to follow recognized and established national and/or&#xD;
      international guidelines whenever possible. Nevertheless, deviation from guidelines may be&#xD;
      necessary in specific cases. The decision whether and when to deviate from guidelines is at&#xD;
      the discretion of the responsible physician and nursing staff and is taken to the best&#xD;
      individual knowledge. Patients with ADHF admitted to the Intensive Care Unit are not included&#xD;
      in this study. Patients not requiring intensive care treatment will be hospitalized on a&#xD;
      regular medical ward and treated with diuretics to improve symptoms of congestion. In case a&#xD;
      patient is transferred to the Intensive Care Unit after study inclusion, further data from&#xD;
      date of transfer onwards will not be collected, to avoid discomfort to patients and medical&#xD;
      personal while the patient is in a critical situation. The study itself is also composed for&#xD;
      treatments on a regular medical ward. The transfer to the Intensive Care Unit will serve as&#xD;
      the endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2018</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In the intervention arm serial measurement of NT-proBNP will be made available to the treating physician. A control group continuing to undergo care according to the 2016 ESC Guidelines will serve as comparator. Changes in NT-proBNP levels, safety laboratory parameters such as sodium, potassium, creatinine, HF medication, vital signs, body weight and BMI, QoL, length of hospital stay, NYHA functional class, adverse events, transfer to the Intensive Care Unit and mortality will be recorded in patients with ADHF.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in NT-proBNP</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Meassurement of NT-proBNP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage and variations in medication to treat heart failure</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Changes in medical heart failure therapies such as Diuretics, Nitrates, Angiotensin-converting-enzyme (ACE) Inhibitors or angiotensin-receptor blockers (ARBs), Beta blocker</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HR (in beats/min)</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BP (in mmHg)</measure>
    <time_frame>Through study completion, on average 10 days</time_frame>
    <description>Vital sign</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI and Body weight</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Body mass index and weight in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KCCQ (Kansas City Cardiomyopathy ) Questionnaire</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>The KCCQ is a self-administered, 23-item questionnaire measuring HRQoL in patients with CHF regardless of its origin. Each item has a 5-, 6-, or 7-point Likert scale. The questionnaire assesses six domains of HRQoL: Physical Limitation, Symptoms, Symptom Stability, Social Limitation, Self-Efficacy, and Quality of Life. Domain scores were transformed to 0-100 (highest level of functioning) scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF12 (Short Form 12 Health Survey ) Questionnaire</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>A mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minnesota LIVING WITH HEART FAILURE® Questionnaire</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.&#xD;
The instrument can be used as a key outcome measure in studies and evaluations of outpatients with symptomatic (NYHA class II to IV) heart failure with a reduced or preserved ejection fraction. This patient-reported outcome can be used to determine whether a treatment for heart failure is effective for improving patients' quality of life by reducing the adverse impact of heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Meassurement of potassium as safety parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Meassurement of sodium as safety parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Meassurement of creatinine as safety parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>Days spent in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA functional class</measure>
    <time_frame>Up to 4 weeks, on average 10 days</time_frame>
    <description>NYHA class I-IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer to the Intensive Care Unit (ICU)</measure>
    <time_frame>Number pf patients</time_frame>
    <description>Stay at ICU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Acute Decompensated Heart Failure</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group A: Patients allocated to the control group will undergo the measurements at inclusion and discharge visit. The control group conduces to compare the NT-proBNP and HF medication changes under therapy monitoring with serial NT-proBNP measurements to the NT-proBNP and HF medication changes with sign and symptom guided HF therapy. The diagnostic and therapeutic decisions in the control Group and in the Intervention group will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal. At discharge, the same measurements as at the inclusion visit will be repeated in all patients to monitor the effects associated with the participation in this trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POC-available group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B:Patients allocated to the intervention group (POC-available group) will undergo serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day. The blood collection (10 ml of Lithium Heparin blood) for these tests will be done in the morning together with the regularly blood collection. The study team does the the analysis on the study devices. The result of the test will be provided directly to the responsible physician. Treatment changes are at the discretion of the responsible physician. The physician will be alerted by a phone call of a study member if the NT-proBNP hasn't decreased by 10% or more between two measurements. But no specific recommendations with regards to therapy will be provided by the investigator or his team. However, diagnostic and therapeutic decisions will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day</intervention_name>
    <description>Serial measurements of NT-proBNP, sodium, potassium, and creatinine in the NT-proBNP-group vs. no serial measurements in control group. In the intervention group the body weight, vital parameters, therapy changes and adverse events are documented the above mention serial measurement every second business day.</description>
    <arm_group_label>POC-available group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  NYHA functional class II or III&#xD;
&#xD;
          -  Symptoms of heart failure:&#xD;
&#xD;
        E.g.: Dyspnea Paroxysmal nocturnal dyspnea Reduced exercise capacity Fatigue Extended&#xD;
        recovery after exercising Peripheral edema (lower leg, ankle) NT-proBNP &gt;300 (pg/ml)&#xD;
&#xD;
          -  Age &gt; 18 Years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NYHA functional class I or IV&#xD;
&#xD;
          -  NT-proBNP &lt; 1200 pg/ml and creatinine clearance &lt; 60 ml/min (Clearance (ml/min) =&#xD;
             1.23(women 1.03) x body weight (Kg) x (140-Age)/ creatinine (umol/L)) Creatinine&#xD;
             clearence: ___________ &lt;60ml/min&#xD;
&#xD;
          -  Heart failure due to chemotherapeutic drugs&#xD;
&#xD;
          -  Uncontrolled brady- or tachyarrythmia&#xD;
&#xD;
          -  Unstable angina pectoris&#xD;
&#xD;
          -  Severe uncorrected valvular disease&#xD;
&#xD;
          -  Planned cardiac intervention in the next 6 months&#xD;
&#xD;
          -  Clinically significant concomitant disease states:&#xD;
&#xD;
        On-going cancer treatment&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Immunosuppressive medical therapy&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the study procedures (Due to language problems, psychological&#xD;
             disorders, dementia, etc.)&#xD;
&#xD;
          -  Participation in another intervention study&#xD;
&#xD;
          -  Enrolment of investigators or their family members&#xD;
&#xD;
          -  Pregnancy, lactation, breast feeding&#xD;
&#xD;
          -  Positive pregnancy test for females in childbearing age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jörg D. Leuppi, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Medical University Clinic, Cantonal hospital Baselland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cantonal Hospital Baselland Liestal</name>
      <address>
        <city>Liestal</city>
        <state>BL</state>
        <zip>4410</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hosptal, Baselland</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Jörg Leuppi</investigator_full_name>
    <investigator_title>Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04471610
org study id: 2017-01030
nct id: NCT04471610
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to explore whether the availability of serial NT-proBNP
      measurements together with safety parameters such as electrolytes and creatinine may
      influence treatment decision in patients with acute decompensated heart failure (ADHF)
      leading to more rapid and faster dose increase of prognostic therapies and earlier hospital
      discharge.
The proposed study is a prospective, unblinded, single center, 2-arm randomized controlled
      pilot trial. In the intervention arm serial measurement of NT-proBNP will be made available
      to the treating physician. A control group continuing to undergo care according to the 2016
      ESC Guidelines will serve as comparator. Changes in NT-proBNP levels, safety laboratory
      parameters such as sodium, potassium, creatinine, Heart failure (HF) medication, vital signs,
      body weight and BMI, Quality of Life (QoL), length of hospital stay, New York Heart
      Association (NYHA) functional class, adverse events, transfer to the Intensive Care Unit and
      mortality will be recorded in patients with ADHF.

      The Kantonsspital Baselland (KSBL) Liestal will be the only study center. All members of the
      study group will the thoroughly instructed regarding study procedures. Inclusion visits will
      be conducted only by a member of the study group. All Patients with ADHF on the medical ward
      of the KSBL Liestal will be provided an information sheet regarding goals and procedures of
      the study and the informed consent. Inclusion criteria will be checked after admission.
      Patients not matching the inclusion criteria at the screening visit cannot participate in
      this study. Patients will be provided sufficient time for their decision. The investigators
      communicate clearly that participation in the study is absolutely voluntary and refusal of
      participation has no influence on treatment during hospitalization.

      In order to minimize bias that may be introduced by even minor differences in executing and
      interpreting technical exams, all study related measurements and procedures will be performed
      in a centralized manner at the KSBL Liestal.

      Patients will be included only after approval of informed consent. Randomization is performed
      using 50 closed envelopes containing a paper shit with either the letter A or B. In total
      there are 25 A's and 25 B's. The letter A stands for the control group and the letter B for
      the intervention group. These envelopes are mixed initially, numbered for order purposes and
      the order maintained throughout the study. The name of the patient will be written down on
      the envelope. Then it will be open and the patient will be allocated to the study group
      depending on the letter in the envelope. All patients will undergo an inclusion and discharge
      visit. General demographic data, including age, gender, nationality, smoking status, alcohol
      consumption, current profession, exercise behavior, allergies, medication, HF history and
      comorbidities will be recorded. Assessment of vital signs and body weight will be performed
      together with an electrocardiogram, several laboratory tests (NT-proBNP, potassium, sodium
      and creatinine). In addition, questionnaires concerning QoL (SF-12, KCCQ, MLWHFQ) will be
      filled in by the participants. Women who can get pregnant (not yet in menopause and last
      menstrual period less than 12 months, not surgically sterilized, ovaries and/or uterus not
      removed) will have to undergo a pregnancy test prior to inclusion into the study.

      Patients allocated to the intervention group (POC-available group) will undergo serial
      measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day. The
      investigators have chosen this time-lag because an earlier time point would not show the
      change of the security parameter creatinine due to longer half-life-time. For this test,
      blood is collected from the patients. These samplings will be done in the morning together
      with the regularly blood collection through the attending nurse according to the established
      procedure of the KSBL Liestal in the morning. 10ml blood will be collected for this study
      during each blood sample with a standard Lithium-blood-collection tube. Members of the study
      team will collect the blood samples and analyses them on the study devices. The result of the
      test will be provided directly to the responsible physician of the medical department at the
      KSBL Liestal. Treatment changes are at the discretion of the responsible physician. The
      physician will be alerted by a phone call of a study member if the NT-proBNP hasn't decreased
      by 10% or more between two measurements. But no specific recommendations with regards to
      therapy will be provided by the investigator or his team. However, diagnostic and therapeutic
      decisions will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF
      as established at the KSBL Liestal.

      Patients allocated to the control group will undergo the measurements at inclusion and
      discharge visit. The control group conduces to compare the NT-proBNP and HF medication
      changes under therapy monitoring with serial NT-proBNP measurements to the NT-proBNP and HF
      medication changes with sign and symptom guided HF therapy. As in the intervention group,
      diagnostic and therapeutic decisions in the control group will be based on the current 2016
      ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal. At
      discharge, the same measurements as at the inclusion visit will be repeated in all patients
      to monitor the effects associated with the participation in this trial.

      Total study duration will cover a period of approximately 3 years. Patients will be screened
      until a total of 25 patients are included per study group.

      Overall, 50 patients are planned to be recruited. Recruitment is estimated to start in
      September 2017 and end at the latest in March 2020 after discharge of the last hospitalized
      patient included in the study. Data collection of the study is expected to be completed by
      May 2020 and data analysis by December 2020.

      The expected duration of the study for each patient will be defined by the time period from
      inclusion to discharge and is expected to be in the range of 8-12 days (=average time for HF
      hospitalization of our institution).

      As an university institution, the KSBL Liestal mandates its physician and nursing staff to
      provide evidence-based medical care and to follow recognized and established national and/or
      international guidelines whenever possible. Nevertheless, deviation from guidelines may be
      necessary in specific cases. The decision whether and when to deviate from guidelines is at
      the discretion of the responsible physician and nursing staff and is taken to the best
      individual knowledge. Patients with ADHF admitted to the Intensive Care Unit are not included
      in this study. Patients not requiring intensive care treatment will be hospitalized on a
      regular medical ward and treated with diuretics to improve symptoms of congestion. In case a
      patient is transferred to the Intensive Care Unit after study inclusion, further data from
      date of transfer onwards will not be collected, to avoid discomfort to patients and medical
      personal while the patient is in a critical situation. The study itself is also composed for
      treatments on a regular medical ward. The transfer to the Intensive Care Unit will serve as
      the endpoint.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In the intervention arm serial measurement of NT-proBNP will be made available to the treating physician. A control group continuing to undergo care according to the 2016 ESC Guidelines will serve as comparator. Changes in NT-proBNP levels, safety laboratory parameters such as sodium, potassium, creatinine, HF medication, vital signs, body weight and BMI, QoL, length of hospital stay, NYHA functional class, adverse events, transfer to the Intensive Care Unit and mortality will be recorded in patients with ADHF.
primary purpose: Other
masking: None (Open Label)
measure: Changes in NT-proBNP
time frame: Up to 4 weeks, on average 10 days
description: Meassurement of NT-proBNP
measure: Dosage and variations in medication to treat heart failure
time frame: Up to 4 weeks, on average 10 days
description: Changes in medical heart failure therapies such as Diuretics, Nitrates, Angiotensin-converting-enzyme (ACE) Inhibitors or angiotensin-receptor blockers (ARBs), Beta blocker
measure: HR (in beats/min)
time frame: Up to 4 weeks, on average 10 days
description: Vital signs
measure: BP (in mmHg)
time frame: Through study completion, on average 10 days
description: Vital sign
measure: BMI and Body weight
time frame: Up to 4 weeks, on average 10 days
description: Body mass index and weight in kg
measure: KCCQ (Kansas City Cardiomyopathy ) Questionnaire
time frame: Up to 4 weeks, on average 10 days
description: The KCCQ is a self-administered, 23-item questionnaire measuring HRQoL in patients with CHF regardless of its origin. Each item has a 5-, 6-, or 7-point Likert scale. The questionnaire assesses six domains of HRQoL: Physical Limitation, Symptoms, Symptom Stability, Social Limitation, Self-Efficacy, and Quality of Life. Domain scores were transformed to 0-100 (highest level of functioning) scales.
measure: SF12 (Short Form 12 Health Survey ) Questionnaire
time frame: Up to 4 weeks, on average 10 days
description: A mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
measure: Minnesota LIVING WITH HEART FAILURE® Questionnaire
time frame: Up to 4 weeks, on average 10 days
description: The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
The instrument can be used as a key outcome measure in studies and evaluations of outpatients with symptomatic (NYHA class II to IV) heart failure with a reduced or preserved ejection fraction. This patient-reported outcome can be used to determine whether a treatment for heart failure is effective for improving patients' quality of life by reducing the adverse impact of heart failure.
measure: Potassium
time frame: Up to 4 weeks, on average 10 days
description: Meassurement of potassium as safety parameter
measure: Sodium
time frame: Up to 4 weeks, on average 10 days
description: Meassurement of sodium as safety parameter
measure: Creatinine
time frame: Up to 4 weeks, on average 10 days
description: Meassurement of creatinine as safety parameter
measure: Length of hospital stay
time frame: Up to 4 weeks, on average 10 days
description: Days spent in the hospital
measure: NYHA functional class
time frame: Up to 4 weeks, on average 10 days
description: NYHA class I-IV
measure: Transfer to the Intensive Care Unit (ICU)
time frame: Number pf patients
description: Stay at ICU
arm group label: Control group
arm group type: No Intervention
description: Group A: Patients allocated to the control group will undergo the measurements at inclusion and discharge visit. The control group conduces to compare the NT-proBNP and HF medication changes under therapy monitoring with serial NT-proBNP measurements to the NT-proBNP and HF medication changes with sign and symptom guided HF therapy. The diagnostic and therapeutic decisions in the control Group and in the Intervention group will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal. At discharge, the same measurements as at the inclusion visit will be repeated in all patients to monitor the effects associated with the participation in this trial.
arm group label: POC-available group
arm group type: Experimental
description: Group B:Patients allocated to the intervention group (POC-available group) will undergo serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day. The blood collection (10 ml of Lithium Heparin blood) for these tests will be done in the morning together with the regularly blood collection. The study team does the the analysis on the study devices. The result of the test will be provided directly to the responsible physician. Treatment changes are at the discretion of the responsible physician. The physician will be alerted by a phone call of a study member if the NT-proBNP hasn't decreased by 10% or more between two measurements. But no specific recommendations with regards to therapy will be provided by the investigator or his team. However, diagnostic and therapeutic decisions will be based on the current 2016 ESC guidelines on the diagnosis and therapy of HF as established at the KSBL Liestal.
intervention type: Other
intervention name: Serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day
description: Serial measurements of NT-proBNP, sodium, potassium, and creatinine in the NT-proBNP-group vs. no serial measurements in control group. In the intervention group the body weight, vital parameters, therapy changes and adverse events are documented the above mention serial measurement every second business day.
arm group label: POC-available group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jörg D. Leuppi, Prof.
role: Principal Investigator
affiliation: Head of Medical University Clinic, Cantonal hospital Baselland
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Cantonal Hosptal, Baselland
investigator full name: Prof. Dr. Jörg Leuppi
investigator title: Professor of Internal Medicine
mesh term: Heart Failure