Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT01677494
Status:
TERMINATED
Last Update Posted:
2014-09-03
First Post:
2010-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collagen Markers in Heart Failure and Preserved Ejection Fraction
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.
Status:
TERMINATED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLLAG4
Brief Summary:
Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: