Collagen Markers in Heart Failure and Preserved Ejection Fraction (COLLAG4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01677494|
Recruitment Status : Terminated (lack of recruitment)
First Posted : September 3, 2012
Last Update Posted : September 3, 2014
|Condition or disease|
|Left-sided Congestive Heart Failure|
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
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics
- - 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.
- - 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.
- - inclusion criteria: Male or female > 18 and < 85 years of age. signed inform consent. Health insurance.
- - 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.
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|Official Title:||To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
heart failure with preserved ejection fraction
- Inclusion Elevated BNP EF > 50%
- death and admission for heart failure [ Time Frame: 2 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677494
|Rouen university hospital|
|Rouen, France, 76031|
|Principal Investigator:||Fabrice Bauer, MD, PhD||Rouen University Hospital|