<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/NCT03782337</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG8H1271</org_study_id>
    <nct_id>NCT03782337</nct_id>
  </id_info>
  <brief_title>The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients</brief_title>
  <official_title>The Predictors and Benefits of Multi-discipline Disease Management Program in Heart Failure Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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 investigator will investigate the predictors includes cardiac biomarkers, endothelial&#xD;
      function and cardiopulmonary exercise test in prediction of cardiovascular outcome in&#xD;
      patients with heart failure discharged from hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Readmission and mortality are high after heart failure (HF) hospitalization.&#xD;
      Heart Failure Multi-discipline disease management program (HFDMP) has shown to decrease 30%&#xD;
      in readmission for decompensated heart failure or other cardiovascular causes. This was&#xD;
      associated with a decreased in medical cost of care and a trend towards a lower mortality&#xD;
      rate. Despite evidence that HFDMPs is effective, however, they are not widely employed in&#xD;
      Taiwan. Some HFDMPs did not show improved health status compared with usual care. The &quot;best&#xD;
      way&quot; to design and implement a HFDMP is not clear. It is still not clear if HFDMP would&#xD;
      benefit all heart failure patients or should instead be targeted to specific subsets. Lysyl&#xD;
      oxidase-like 2 (Loxl2) is enzyme, which crosslinks collagen in fibrotic processes such like&#xD;
      liver cirrhosis or lung fibrosis. Recently, Lysyl oxidase-like 2 (Loxl2) was also found to&#xD;
      participate the process of cardiac interstitial fibrosis and heart failure. Interestingly,&#xD;
      the serum level of Loxl2 is in good correlation with the severity of heart failure. However,&#xD;
      there is still unknown whether Loxl2 is useful biomarker for predicting the long-term outcome&#xD;
      in patient with heart failure. From the mechanism of Loxl2 in the process of heart failure,&#xD;
      the serum level of Loxl2 may be a good maker for predict the degree of cardiac remodeling.&#xD;
      Our animal study showed the correlation between myocardial fibrosis and Loxl2 serum level.&#xD;
      Therefore, The investigator will investigate whether serum Loxl2 level is a good maker for&#xD;
      predictor the long-term outcome in patient with heart failure and predictor of cardiac&#xD;
      remodeling. The correlation between this novel cardiac biomarker and endothelial function,&#xD;
      cardiopulmonary function test will also be evaluated.&#xD;
&#xD;
      Objectives: The investigator will investigate the predictors includes cardiac biomarkers (&#xD;
      such as serum Loxl2 level, B-type natriuretic peptide (BNP), soluble ST2), endothelial&#xD;
      function and cardiopulmonary exercise test in prediction of cardiovascular outcome and&#xD;
      reverse remodeling in patients with heart failure discharged from hospital.&#xD;
&#xD;
      Design: A prospective cohort study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Readmission</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF readmission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score</measure>
    <time_frame>Baseline, Month 6 , Month 12</time_frame>
    <description>Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants - All-cause Mortality</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure (HF) patients. This measures how many patients had this event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques</measure>
    <time_frame>12 months</time_frame>
    <description>Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques from patient discharge to 12 months after</description>
  </secondary_outcome>
  <enrollment type="Actual">162</enrollment>
  <condition>Heart Failure With Decompensation</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>multi-discipline disease management program</intervention_name>
    <description>The multi-discipline disease management program consists of nursing lead education program, dietitian consultation, psychologist consultation and assessment, and cardiac rehabilitation program by physical therapist.The cardiovascular lead nurse will contact the patient by telephone within 3 days after discharge. An appointment at the outpatient clinic will be arranged within 1 to 2 weeks after discharge. The purposes of the telephone call are to reinforce self-management and recognition of HF symptoms and to screen post-discharge health status.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. Biomarkers for cardiovascular disease, e.g., sST2, GDF15, and DNA testing for&#xD;
           arrhythmogenic cardiomyopathy.&#xD;
&#xD;
        2. Cytokines, e.g., inflammation cytokines.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients population who admitted to a referred medical center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must give written informed consent before any assessment is performed.&#xD;
&#xD;
          2. Inpatients ≥ 18 years of age, male or female.&#xD;
&#xD;
          3. Patients with a diagnosis of heart failure New York Heart Association (NYHA) class&#xD;
             II-IV with BNP &gt;100 pg/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Estimated survival time &lt; 6 months&#xD;
&#xD;
          2. Long-term bedridden more than 3 months&#xD;
&#xD;
          3. Cannot tolerance exercise test due to muscular skeletal disorder&#xD;
&#xD;
          4. Cannot co-operate all functional studies&#xD;
&#xD;
          5. Ventilator dependent&#xD;
&#xD;
          6. Terminal heart status&#xD;
&#xD;
          7. Family reject to participate this project&#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>Shyh-Ming Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital Heart Failure Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital Heart Failure Center</name>
      <address>
        <city>Kaohsiung</city>
        <state>Bird Pine Area</state>
        <zip>83341</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart failure,</keyword>
  <keyword>Cardiac biomarker</keyword>
  <keyword>Cardiopulmonary exercise test</keyword>
  <keyword>Multi-discipline disease management program</keyword>
  <keyword>Reverse remodeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We will discuss with other investigators about individual participant data (IPD) sharing.</ipd_description>
  </patient_data>
  <!-- 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/NCT03782337
org study id: CMRPG8H1271
nct id: NCT03782337
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator will investigate the predictors includes cardiac biomarkers, endothelial
      function and cardiopulmonary exercise test in prediction of cardiovascular outcome in
      patients with heart failure discharged from hospital.
Background: Readmission and mortality are high after heart failure (HF) hospitalization.
      Heart Failure Multi-discipline disease management program (HFDMP) has shown to decrease 30%
      in readmission for decompensated heart failure or other cardiovascular causes. This was
      associated with a decreased in medical cost of care and a trend towards a lower mortality
      rate. Despite evidence that HFDMPs is effective, however, they are not widely employed in
      Taiwan. Some HFDMPs did not show improved health status compared with usual care. The "best
      way" to design and implement a HFDMP is not clear. It is still not clear if HFDMP would
      benefit all heart failure patients or should instead be targeted to specific subsets. Lysyl
      oxidase-like 2 (Loxl2) is enzyme, which crosslinks collagen in fibrotic processes such like
      liver cirrhosis or lung fibrosis. Recently, Lysyl oxidase-like 2 (Loxl2) was also found to
      participate the process of cardiac interstitial fibrosis and heart failure. Interestingly,
      the serum level of Loxl2 is in good correlation with the severity of heart failure. However,
      there is still unknown whether Loxl2 is useful biomarker for predicting the long-term outcome
      in patient with heart failure. From the mechanism of Loxl2 in the process of heart failure,
      the serum level of Loxl2 may be a good maker for predict the degree of cardiac remodeling.
      Our animal study showed the correlation between myocardial fibrosis and Loxl2 serum level.
      Therefore, The investigator will investigate whether serum Loxl2 level is a good maker for
      predictor the long-term outcome in patient with heart failure and predictor of cardiac
      remodeling. The correlation between this novel cardiac biomarker and endothelial function,
      cardiopulmonary function test will also be evaluated.

      Objectives: The investigator will investigate the predictors includes cardiac biomarkers (
      such as serum Loxl2 level, B-type natriuretic peptide (BNP), soluble ST2), endothelial
      function and cardiopulmonary exercise test in prediction of cardiovascular outcome and
      reverse remodeling in patients with heart failure discharged from hospital.

      Design: A prospective cohort study
observational model: Cohort
time perspective: Prospective
measure: Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Readmission
time frame: up to 36 months
description: Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF readmission.
measure: Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score
time frame: Baseline, Month 6 , Month 12
description: Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
measure: Number of Participants - All-cause Mortality
time frame: up to 36 months
description: Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure (HF) patients. This measures how many patients had this event.
measure: Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques
time frame: 12 months
description: Number of Participants with changes in ventricular shape using echocardiographic endocardial surface analysis techniques from patient discharge to 12 months after
intervention type: Behavioral
intervention name: multi-discipline disease management program
description: The multi-discipline disease management program consists of nursing lead education program, dietitian consultation, psychologist consultation and assessment, and cardiac rehabilitation program by physical therapist.The cardiovascular lead nurse will contact the patient by telephone within 3 days after discharge. An appointment at the outpatient clinic will be arranged within 1 to 2 weeks after discharge. The purposes of the telephone call are to reinforce self-management and recognition of HF symptoms and to screen post-discharge health status.
1. Biomarkers for cardiovascular disease, e.g., sST2, GDF15, and DNA testing for
           arrhythmogenic cardiomyopathy.

        2. Cytokines, e.g., inflammation cytokines.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shyh-Ming Chen, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital Heart Failure Center
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided
ipd description: We will discuss with other investigators about individual participant data (IPD) sharing.