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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.

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01677494
Acronym
COLLAG4
Enrollment
84
Registered
2012-09-03
Start date
2010-09-30
Completion date
2013-08-31
Last updated
2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left-sided Congestive Heart Failure

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.

Interventions

None listed

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
death and admission for heart failure2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026