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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01716819
First received: October 26, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obesity, Abdominal
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • cardiac extracellular matrix remodelling [ Time Frame: 3-7 years ] [ Designated as safety issue: No ]
    Initial values of cardiac extracellular matrix remodelling biomarkers and the evolution of biomarkers at 3-7 years


Secondary Outcome Measures:
  • Cardiac and arterial phenotype [ Time Frame: 3-7 years ] [ Designated as safety issue: No ]
    Evolution of cardiac and vascular phenotype in 3-7 years.


Estimated Enrollment: 116
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Urine sample
dosages on one spot and 24h collection
Other: Blood sample
dosages
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   43 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716819

Contacts
Contact: Patrick ROSSIGNOL +33383157320 p.rossignol@chu-nancy.fr
Contact: Faiez ZANNAD +33383157320 f.zannad@chu-nancy.fr

Locations
France
CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Recruiting
Vandoeuvre Lès Nancy, Meurthe et Moselle, France, 54500
Contact: Patrick ROSSIGNOL    +33 3 83 15 73 20    p.rossignol@chu-nancy.fr   
Sub-Investigator: Faiez ZANNAD         
Sub-Investigator: Pierre-Yves MARIE         
Sub-Investigator: Jean-Marc BOIVIN         
Sub-Investigator: Daniela DOBRE         
Sub-Investigator: José MEDINA         
Sub-Investigator: Damien MANDRY         
Sub-Investigator: Wassila DJABALLAH         
Sub-Investigator: Cédric PASQUIER         
Sub-Investigator: Jacques FELBLINGER         
Sub-Investigator: Anne PIZARD         
Sub-Investigator: Bruno GUERCI         
Sub-Investigator: Philippe BOHME         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Patrick ROSSIGNOL CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01716819     History of Changes
Other Study ID Numbers: 2012-A00574-39
Study First Received: October 26, 2012
Last Updated: February 24, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Central Hospital, Nancy, France:
Heart failure, abdominal obesity, RAAS

Additional relevant MeSH terms:
Heart Failure
Obesity
Obesity, Abdominal
Body Weight
Cardiovascular Diseases
Heart Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014