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

Obesity, Abdominal Clinical Trial

— R2C2-II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716819
• Other study ID #: 2012-A00574-39
• Status: Completed
• Phase: N/A
• First received: October 26, 2012
• Last updated: August 21, 2015
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 43 Years to 72 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Failure
• Obesity
• Obesity, Abdominal

Intervention

Other:
• Urine sample
dosages on one spot and 24h collection
• Blood sample
dosages
• Assessment of sleep apnea syndrome

• Electrocardiogram

• Glucose tolerance test

• Echocardiography

• cardiac and abdominal magnetic resonance imaging

• Ambulatory blood pressure monitoring

• Echotracking

• Pulse wave velocity

• Composition of body mass by Dual x-ray absorptiometry

Locations

Country	Name	City	State
France	CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux	Vandoeuvre Lès Nancy	Meurthe et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac extracellular matrix remodelling	Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years	3-7 years	No
Secondary	Cardiac and arterial phenotype	Evolution of cardiac and vascular phenotype in 3-7 years.	3-7 years	No