<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/NCT01716819</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00574-39</org_study_id>
    <nct_id>NCT01716819</nct_id>
  </id_info>
  <brief_title>Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity</brief_title>
  <acronym>R2C2-II</acronym>
  <official_title>Role of the Renin Angiotensin Aldosterone System and Remodeling of the Matrix Cardiac Extra Cellular in the Mechanisms of Transition to Heart Failure in Abdominal Obesity: Prospective Longitudinal Study R2C2 II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular&#xD;
      remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin&#xD;
      aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to&#xD;
      confirm the hypothesis that RAAS is associated with an early remodelling and implicated in&#xD;
      the transition to cardiac failure in abdominal obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Follow up of abdominal obesity patients from the R2C2 cohort study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiac extracellular matrix remodelling</measure>
    <time_frame>3-7 years</time_frame>
    <description>Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac and arterial phenotype</measure>
    <time_frame>3-7 years</time_frame>
    <description>Evolution of cardiac and vascular phenotype in 3-7 years.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Obesity, Abdominal</condition>
  <arm_group>
    <arm_group_label>Abdominal obesity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm, follow up cohort in patient with abdominal obesity. No comparator: description of interventions :&#xD;
Composition of body mass by Dual x-ray absorptiometry Pulse wave velocity Electrocardiogram Urine sample Blood sample (and biological collection) Assessment of sleep apnea syndrome Glucose tolerance test Echocardiography Echotracking cardiac and abdominal magnetic resonance imaging Ambulatory blood pressure monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urine sample</intervention_name>
    <description>dosages on one spot and 24h collection</description>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>dosages</description>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of sleep apnea syndrome</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glucose tolerance test</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardiac and abdominal magnetic resonance imaging</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ambulatory blood pressure monitoring</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Echotracking</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulse wave velocity</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Composition of body mass by Dual x-ray absorptiometry</intervention_name>
    <arm_group_label>Abdominal obesity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a former member of R2C2 study, abdominal obese group.&#xD;
&#xD;
          -  Having signed the informed consent (refusing to participate to the genetic study is&#xD;
             not an exclusion criteria).&#xD;
&#xD;
          -  being affiliated to health insurance scheme.&#xD;
&#xD;
        Inclusion Criteria of R2C2 study:&#xD;
&#xD;
          -  Men and women aged between 40 and 65 year's old&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  Born or living in France for at least 10 years&#xD;
&#xD;
          -  Presenting an abdominal obesity defined by a waist circumference &gt;94 cm in men and ≥&#xD;
             80 cm in women, associated or not with untreated hypertension or hypertension treated&#xD;
             for less than one year&#xD;
&#xD;
          -  Having signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unable to understand the information letter&#xD;
&#xD;
          -  Subjects under supervision or guardianship&#xD;
&#xD;
          -  pregnant or lactating woman&#xD;
&#xD;
          -  A contraindication to perform MRI is not an exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>43 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick ROSSIGNOL</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux</name>
      <address>
        <city>Vandoeuvre Lès Nancy</city>
        <state>Meurthe et Moselle</state>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>August 21, 2015</last_update_submitted>
  <last_update_submitted_qc>August 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart failure, abdominal obesity, RAAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</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/NCT01716819
org study id: 2012-A00574-39
nct id: NCT01716819
lead sponsor: 
has dmc: No
R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular
      remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin
      aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to
      confirm the hypothesis that RAAS is associated with an early remodelling and implicated in
      the transition to cardiac failure in abdominal obesity.
Follow up of abdominal obesity patients from the R2C2 cohort study.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: cardiac extracellular matrix remodelling
time frame: 3-7 years
description: Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years
measure: Cardiac and arterial phenotype
time frame: 3-7 years
description: Evolution of cardiac and vascular phenotype in 3-7 years.
arm group label: Abdominal obesity
arm group type: Other
description: Single arm, follow up cohort in patient with abdominal obesity. No comparator: description of interventions :
Composition of body mass by Dual x-ray absorptiometry Pulse wave velocity Electrocardiogram Urine sample Blood sample (and biological collection) Assessment of sleep apnea syndrome Glucose tolerance test Echocardiography Echotracking cardiac and abdominal magnetic resonance imaging Ambulatory blood pressure monitoring
intervention type: Other
intervention name: Urine sample
description: dosages on one spot and 24h collection
arm group label: Abdominal obesity
intervention type: Other
intervention name: Blood sample
description: dosages
arm group label: Abdominal obesity
intervention type: Other
intervention name: Assessment of sleep apnea syndrome
arm group label: Abdominal obesity
intervention type: Other
intervention name: Electrocardiogram
arm group label: Abdominal obesity
intervention type: Other
intervention name: Glucose tolerance test
arm group label: Abdominal obesity
intervention type: Other
intervention name: Echocardiography
arm group label: Abdominal obesity
intervention type: Other
intervention name: cardiac and abdominal magnetic resonance imaging
arm group label: Abdominal obesity
intervention type: Other
intervention name: Ambulatory blood pressure monitoring
arm group label: Abdominal obesity
intervention type: Other
intervention name: Echotracking
arm group label: Abdominal obesity
intervention type: Other
intervention name: Pulse wave velocity
arm group label: Abdominal obesity
intervention type: Other
intervention name: Composition of body mass by Dual x-ray absorptiometry
arm group label: Abdominal obesity
criteria: 
gender: All
minimum age: 43 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick ROSSIGNOL
role: Principal Investigator
affiliation: CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Obesity
mesh term: Obesity, Abdominal