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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University Hospital, Rouen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01677494
First received: December 2, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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


Condition
Left-sided Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • death and admission for heart failure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Proteomics


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Groups/Cohorts
heart failure with preserved ejection fraction
- Inclusion Elevated BNP EF > 50%

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

heart failure with preserved ejection fraction

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677494

Locations
France
Rouen university hospital Recruiting
Rouen, France, 76031
Contact: Fabrice Bauer, MD, PhD       fabrice.bauer@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Fabrice Bauer, MD, PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01677494     History of Changes
Other Study ID Numbers: 2010/068/HP
Study First Received: December 2, 2010
Last Updated: August 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014