Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

Heart Failure Clinical Trial

Official title:

Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01374880
• Other study ID #: CNIL number: 910198
• Secondary ID: Unité 942 INSERM
• Status: Recruiting
• Phase: N/A
• First received: April 26, 2011
• Last updated: August 13, 2013
• Start date: June 2009
• Est. completion date: January 2014

Study information

• Verified date: June 2013
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Alexandre Mebazaa, PHD
• Phone: +33(0)149958071
• Email: alexandre.mebazaa[@]lrb.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The objective of this work is to investigate and then to sequence new biomarkers in the plasma of patients presenting with dyspnea secondary or not to heart failure, and study their diagnostic and prognostic value.

Description:

Plasma samples for patients with dyspnea, edema, with or without heart failure; ambulatory or admitted for cardiac decompensation (even with cardiac shock and LVAD) ; or entering a cardiac rehabilitation program, will be prospectively collected.

The objective of this work is to investigate and then to sequence new proteins in the plasma of these patients for diagnostic and prognostic purpose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting with shortness of breath secondary or not to heart failure, even with cardiac shock and LVAD.

• Patients with valvular disease

• chronic stable heart failure.

• post- partum Cardiomyopathy

Exclusion Criteria:

• terminal cancer

• progressive neurological disease

• pregnancy

• opposition of the patient

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea
• Heart Diseases
• Heart Failure
• Lung Diseases
• Pulmonary Disease

Locations

Country	Name	City	State
France	Lariboisiere hospital	Paris	Ile de France

Sponsors (19)

Lead Sponsor

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Alere San Diego, Assistance Publique - Hôpitaux de Paris, Brno University Hospital, Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria, Helsinki University Central Hospital, Hoffmann-La Roche, Hospital Universitario Virgen de la Arrixaca, Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan, Maastricht University Medical Center, Massachusetts General Hospital, Servier, The Cleveland Clinic, ThermoFisher Scientific Brahms Biomarkers France, Università degli Studi di Brescia, University Hospital Monastir, Tunis, University Hospital, Basel, Switzerland, University of Cape Town, University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term cardiovascular mortality	To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.	Prospective at 12 months	No
Secondary	Cardiac hospitalization(s) at 3, 6,12 and 24 months	We assess cardiac morbidity within 3, 6, and 24 months months after admission	Prospective at 12 months	No
Secondary	Diagnostic value of new biomarkers.	Assess accuracy of new biomarkers to discriminate heart failure from non-heart failure (negative and positive predictive values)	at day 0	No