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

Not Applicable

Completed

• Conditions: Obesity, Abdominal
• Interventions: Other: Urine sample; Other: Blood sample; Other: 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

• Registration Number: NCT01716819
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Study Start: 2012-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abdominal obesity	cardiac and abdominal magnetic resonance imaging	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
Abdominal obesity	Echocardiography	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
Abdominal obesity	Echotracking	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
Abdominal obesity	Blood sample	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
Abdominal obesity	Glucose tolerance test	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
Abdominal obesity	Composition of body mass by Dual x-ray absorptiometry	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
Abdominal obesity	Urine sample	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
Abdominal obesity	Pulse wave velocity	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
Abdominal obesity	Assessment of sleep apnea syndrome	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
Abdominal obesity	Electrocardiogram	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
Abdominal obesity	Ambulatory blood pressure monitoring	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

Primary Outcome Measures

Name	Time	Method
cardiac extracellular matrix remodelling	3-7 years	Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years

Secondary Outcome Measures

Name	Time	Method
Cardiac and arterial phenotype	3-7 years	Evolution of cardiac and vascular phenotype in 3-7 years.

Trial Locations

Locations (1)

CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux; 🇫🇷 Vandoeuvre Lès Nancy, Meurthe et Moselle, France