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

NCT ID: NCT01716819

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-03-31

Brief Summary

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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

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

Conditions

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Obesity, Abdominal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Urine sample

Intervention Type OTHER

dosages on one spot and 24h collection

Blood sample

Intervention Type OTHER

dosages

Assessment of sleep apnea syndrome

Intervention Type OTHER

Electrocardiogram

Intervention Type OTHER

Glucose tolerance test

Intervention Type OTHER

Echocardiography

Intervention Type OTHER

cardiac and abdominal magnetic resonance imaging

Intervention Type OTHER

Ambulatory blood pressure monitoring

Intervention Type OTHER

Echotracking

Intervention Type OTHER

Pulse wave velocity

Intervention Type OTHER

Composition of body mass by Dual x-ray absorptiometry

Intervention Type OTHER

Interventions

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Urine sample

dosages on one spot and 24h collection

Intervention Type OTHER

Blood sample

dosages

Intervention Type OTHER

Assessment of sleep apnea syndrome

Intervention Type OTHER

Electrocardiogram

Intervention Type OTHER

Glucose tolerance test

Intervention Type OTHER

Echocardiography

Intervention Type OTHER

cardiac and abdominal magnetic resonance imaging

Intervention Type OTHER

Ambulatory blood pressure monitoring

Intervention Type OTHER

Echotracking

Intervention Type OTHER

Pulse wave velocity

Intervention Type OTHER

Composition of body mass by Dual x-ray absorptiometry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being a former member of R2C2 study, abdominal obese group.

* 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

* being affiliated to health insurance scheme.


* Subjects unable to understand the information letter
* Subjects under supervision or guardianship
* pregnant or lactating woman
Minimum Eligible Age

43 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick ROSSIGNOL

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Vandœuvre-lès-Nancy, Meurthe et Moselle, France

Site Status

Countries

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France

References

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Mandry D, Girerd N, Lamiral Z, Huttin O, Filippetti L, Micard E, Beaumont M, Ncho Mottoh MB, Pace N, Zannad F, Rossignol P, Marie PY. Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study. Front Cardiovasc Med. 2021 Dec 24;8:803567. doi: 10.3389/fcvm.2021.803567. eCollection 2021.

Reference Type DERIVED
PMID: 35004914 (View on PubMed)

Other Identifiers

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2012-A00574-39

Identifier Type: -

Identifier Source: org_study_id

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