Collagen Markers in Heart Failure and Preserved Ejection Fraction (COLLAG4)

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01677494
First received: December 2, 2010
Last updated: September 1, 2014
Last verified: September 2014

December 2, 2010
September 1, 2014
September 2010
August 2013   (final data collection date for primary outcome measure)
death and admission for heart failure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01677494 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Collagen Markers in Heart Failure and Preserved Ejection Fraction
To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.

Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Proteomics

Probability Sample

heart failure with preserved ejection fraction

Left-sided Congestive Heart Failure
Not Provided
heart failure with preserved ejection fraction
- Inclusion Elevated BNP EF > 50%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
August 2013
August 2013   (final data collection date for primary outcome measure)

- inclusion Signs of heart failure Elevated BNP EF > 50% within 72 hours after admission

Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01677494
2010/068/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Fabrice Bauer, MD, PhD Rouen University Hospital
University Hospital, Rouen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP