Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity (R2C2-II)

August 21, 2015 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Follow up of abdominal obesity patients from the R2C2 cohort study.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Meurthe et Moselle
      • Vandoeuvre Lès Nancy, Meurthe et Moselle, France, 54500
        • CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being a former member of R2C2 study, abdominal obese group.
  • Having signed the informed consent (refusing to participate to the genetic study is not an exclusion criteria).
  • being affiliated to health insurance scheme.

Inclusion Criteria of R2C2 study:

  • Men and women aged between 40 and 65 year's old
  • Caucasian
  • Born or living in France for at least 10 years
  • Presenting an abdominal obesity defined by a waist circumference >94 cm in men and ≥ 80 cm in women, associated or not with untreated hypertension or hypertension treated for less than one year
  • Having signed the informed consent

Exclusion Criteria:

  • Subjects unable to understand the information letter
  • Subjects under supervision or guardianship
  • pregnant or lactating woman
  • A contraindication to perform MRI is not an exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Abdominal obesity

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
Other: Echocardiography
Other: Glucose tolerance test
Other: Electrocardiogram
Other: Urine sample
dosages on one spot and 24h collection
Other: Blood sample
dosages
Other: Assessment of sleep apnea syndrome
Other: cardiac and abdominal magnetic resonance imaging
Other: Ambulatory blood pressure monitoring
Other: Echotracking
Other: Pulse wave velocity
Other: Composition of body mass by Dual x-ray absorptiometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac extracellular matrix remodelling
Time Frame: 3-7 years
Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years
3-7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac and arterial phenotype
Time Frame: 3-7 years
Evolution of cardiac and vascular phenotype in 3-7 years.
3-7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Patrick ROSSIGNOL, CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00574-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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