Skip to main content
OpenTrials
Completed

NCT Number: NCT01716819

Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity, Abdominal Body Weight Cardiovascular Diseases Heart Diseases Heart Failure Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

43 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux

Vandœuvre-lès-Nancy, Meurthe et Moselle, 54500, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urine sample

Other

dosages on one spot and 24h collection

blood sample

Other

dosages

Assessment of sleep apnea syndrome

Other

Electrocardiogram

Other

Glucose tolerance test

Other

echocardiography

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

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Cardiac and arterial phenotype

    Time frame: 3-7 years

    Evolution of cardiac and vascular phenotype in 3-7 years.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: R2C2-II

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2012
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.