<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/NCT01677494</url>
  </required_header>
  <id_info>
    <org_study_id>2010/068/HP</org_study_id>
    <nct_id>NCT01677494</nct_id>
  </id_info>
  <brief_title>Collagen Markers in Heart Failure and Preserved Ejection Fraction</brief_title>
  <acronym>COLLAG4</acronym>
  <official_title>To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement&#xD;
      imaging), biology (markers of collagen turn-over) and proteomics&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection&#xD;
      fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection&#xD;
      fraction, which represents half of admission has today no efficient treatment.&#xD;
&#xD;
      Fibrosis is found in heart of patients with HF and preserved ejection fraction, is reponsible&#xD;
      for stiff heart and has link to the transition to compensated/decompaseted HF and death.&#xD;
&#xD;
      The purpose of this work is to characterise myocardial fibrosis by any means to change the&#xD;
      prognosis of patients with HF and preserved ejection fraction&#xD;
&#xD;
      Main purpose:&#xD;
&#xD;
      Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement&#xD;
      imaging), biology (markers of collagen turn-over) and proteomics&#xD;
&#xD;
        -  Patients selection&#xD;
&#xD;
             1. - Inclusion Criteria: Male or female &gt; 18 and &lt; 85 years of age. Recent HF&#xD;
                decompensation (framingham criteria, ejection fraction &gt; 50% with 72 hours after&#xD;
                admission and BNP &gt; 100 ng/L or NT-proBNP &gt; 300 ng/L), signed inform consent.&#xD;
&#xD;
             2. - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy,&#xD;
                constrictive pericarditis, significant respiratory disease, pulmonary hypertension,&#xD;
                core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right&#xD;
                ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No&#xD;
                health insurance.&#xD;
&#xD;
        -  Control group&#xD;
&#xD;
             1. - inclusion criteria: Male or female &gt; 18 and &lt; 85 years of age. signed inform&#xD;
                consent. Health insurance.&#xD;
&#xD;
             2. - exclusion criteria: significant ischemic heart disease, significant valvular&#xD;
                heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy,&#xD;
                restrictive cardiomyopathy, constrictive pericarditis, significant respiratory&#xD;
                disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high&#xD;
                cardiac output HF, isolated right ventricular dysfunction, pregnancy or&#xD;
                child-bearing, biventricular pacing, No health insurance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of recruitment&#xD;
  </why_stopped>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>death and admission for heart failure</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Left-sided Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>heart failure with preserved ejection fraction</arm_group_label>
    <description>- Inclusion Elevated BNP EF &gt; 50%</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Proteomics&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        heart failure with preserved ejection fraction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        - inclusion Signs of heart failure Elevated BNP EF &gt; 50% within 72 hours after admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrice Bauer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rouen university hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>December 2, 2010</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01677494
org study id: 2010/068/HP
nct id: NCT01677494
lead sponsor: 
has dmc: No
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement
      imaging), biology (markers of collagen turn-over) and proteomics
Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection
      fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection
      fraction, which represents half of admission has today no efficient treatment.

      Fibrosis is found in heart of patients with HF and preserved ejection fraction, is reponsible
      for stiff heart and has link to the transition to compensated/decompaseted HF and death.

      The purpose of this work is to characterise myocardial fibrosis by any means to change the
      prognosis of patients with HF and preserved ejection fraction

      Main purpose:

      Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement
      imaging), biology (markers of collagen turn-over) and proteomics

        -  Patients selection

             1. - Inclusion Criteria: Male or female > 18 and < 85 years of age. Recent HF
                decompensation (framingham criteria, ejection fraction > 50% with 72 hours after
                admission and BNP > 100 ng/L or NT-proBNP > 300 ng/L), signed inform consent.

             2. - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy,
                constrictive pericarditis, significant respiratory disease, pulmonary hypertension,
                core pulmonale, end-stage kidney disease, high cardiac output HF, isolated right
                ventricular dysfunction, pregnancy or child-bearing, biventricular pacing, No
                health insurance.

        -  Control group

             1. - inclusion criteria: Male or female > 18 and < 85 years of age. signed inform
                consent. Health insurance.

             2. - exclusion criteria: significant ischemic heart disease, significant valvular
                heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy,
                restrictive cardiomyopathy, constrictive pericarditis, significant respiratory
                disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high
                cardiac output HF, isolated right ventricular dysfunction, pregnancy or
                child-bearing, biventricular pacing, No health insurance.
observational model: Cohort
time perspective: Prospective
measure: death and admission for heart failure
time frame: 2 years
arm group label: heart failure with preserved ejection fraction
description: - Inclusion Elevated BNP EF > 50%
Proteomics
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fabrice Bauer, MD, PhD
role: Principal Investigator
affiliation: Rouen University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure