Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01677494 |
| Other study ID # |
2010/068/HP |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
December 2, 2010 |
| Last updated |
September 1, 2014 |
| Start date |
September 2010 |
| Est. completion date |
August 2013 |
Study information
| Verified date |
September 2014 |
| Source |
University Hospital, Rouen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
| Study type |
Observational
|
Clinical Trial Summary
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement
imaging), biology (markers of collagen turn-over) and proteomics
Description:
Heart failure (HF) is a growing public health problem. While HF with deteriorated ejection
fraction has faced numbers of (non) pharmacological advances, HF with preserved ejection
fraction, which represents half of admission has today no efficient treatment.
Fibrosis is found in heart of patients with HF and preserved ejection fraction, is
reponsible for stiff heart and has link to the transition to compensated/decompaseted HF and
death.
The purpose of this work is to characterise myocardial fibrosis by any means to change the
prognosis of patients with HF and preserved ejection fraction
Main purpose:
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement
imaging), biology (markers of collagen turn-over) and proteomics
- Patients selection
1. - Inclusion Criteria: Male or female > 18 and < 85 years of age. Recent HF
decompensation (framingham criteria, ejection fraction > 50% with 72 hours after
admission and BNP > 100 ng/L or NT-proBNP > 300 ng/L), signed inform consent.
2. - exclusion criteria: hypertrophic cardiomyopathy, restrictive cardiomyopathy,
constrictive pericarditis, significant respiratory disease, pulmonary
hypertension, core pulmonale, end-stage kidney disease, high cardiac output HF,
isolated right ventricular dysfunction, pregnancy or child-bearing, biventricular
pacing, No health insurance.
- Control group
1. - inclusion criteria: Male or female > 18 and < 85 years of age. signed inform
consent. Health insurance.
2. - exclusion criteria: significant ischemic heart disease, significant valvular
heart disease, pericarditis, pulmonary hypertension, hypertrophic cardiomyopathy,
restrictive cardiomyopathy, constrictive pericarditis, significant respiratory
disease, pulmonary hypertension, core pulmonale, end-stage kidney disease, high
cardiac output HF, isolated right ventricular dysfunction, pregnancy or
child-bearing, biventricular pacing, No health insurance.
