Collagen Markers in Heart Failure and Preserved Ejection Fraction

NCT ID: NCT01677494

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-08-31

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.

Conditions

Left-sided Congestive Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

heart failure with preserved ejection fraction

\- Inclusion Elevated BNP EF \> 50%

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice Bauer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen university hospital

Rouen, , France

Countries

France

Other Identifiers

2010/068/HP

Identifier Type: -

Identifier Source: org_study_id