NCT01716819

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

October 26, 2012

Last Update Submit

August 21, 2015

Conditions

Obesity, Abdominal

Keywords

Heart failure, abdominal obesity, RAAS

Outcome Measures

Primary Outcomes (1)

  • cardiac extracellular matrix remodelling

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

    3-7 years

Secondary Outcomes (1)

  • Cardiac and arterial phenotype

    3-7 years

Study Arms (1)

Abdominal obesity

OTHER

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 sampleOther: Blood sampleOther: Assessment of sleep apnea syndromeOther: ElectrocardiogramOther: Glucose tolerance testOther: EchocardiographyOther: cardiac and abdominal magnetic resonance imagingOther: Ambulatory blood pressure monitoringOther: EchotrackingOther: Pulse wave velocityOther: Composition of body mass by Dual x-ray absorptiometry

Interventions

Urine sampleOTHER

dosages on one spot and 24h collection

Abdominal obesity
Blood sampleOTHER

dosages

Abdominal obesity
Assessment of sleep apnea syndromeOTHER
Abdominal obesity
ElectrocardiogramOTHER
Abdominal obesity
Glucose tolerance testOTHER
Abdominal obesity
EchocardiographyOTHER
Abdominal obesity
cardiac and abdominal magnetic resonance imagingOTHER
Abdominal obesity
Ambulatory blood pressure monitoringOTHER
Abdominal obesity
EchotrackingOTHER
Abdominal obesity
Pulse wave velocityOTHER
Abdominal obesity
Composition of body mass by Dual x-ray absorptiometryOTHER
Abdominal obesity

Eligibility Criteria

Age43 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • being affiliated to health insurance scheme.
  • 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
  • Subjects unable to understand the information letter
  • Subjects under supervision or guardianship
  • pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

Related Publications (1)

  • 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.

    PMID: 35004914DERIVED

MeSH Terms

Conditions

Obesity, AbdominalHeart Failure

Interventions

Blood Specimen CollectionGlucose Tolerance Test

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBlood Chemical AnalysisClinical Chemistry TestsDiagnostic Techniques, Endocrine

Study Officials

  • Patrick ROSSIGNOL

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2012

First Posted

October 30, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

FR(1)