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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT01374880

Collaborator

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

3,000

Enrollment

Location

Duration (Months)

54.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Dyspnea Pulmonary Disease

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2013

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Dyspnea cohort Dyspnea cohort
Stable chronic heart failure Stable chronic heart failure
Valvular heart disease Valvular heart disease
Ventricular assist device Ventricular assist device
Cardiac arrest Cardiac arrest
Cardiac rehabilitation Cardiac rehabilitation

Outcome Measures

Primary Outcome Measures

Long term cardiovascular mortality [Prospective at 12 months]
To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.

Secondary Outcome Measures

Cardiac hospitalization(s) at 3, 6,12 and 24 months [Prospective at 12 months]
We assess cardiac morbidity within 3, 6, and 24 months months after admission
Diagnostic value of new biomarkers. [at day 0]
Assess accuracy of new biomarkers to discriminate heart failure from non-heart failure (negative and positive predictive values)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lariboisiere hospital	Paris	Ile de France	France	75475

Sponsors and Collaborators

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