Clinical trial NCT01677494: Collagen Markers in Heart Failure and Preserved Ejection Fraction
Official title: To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Left-sided Congestive Heart Failure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: heart failure with preserved ejection fraction

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.

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

Primary outcomes:
measure: death and admission for heart failure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen university hospital
Study officials:
affiliation: University Hospital, Rouen
name: Fabrice Bauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: