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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
University Paris 7 - Denis Diderot
ThermoFisher Scientific Brahms Biomarkers France
Hoffmann-La Roche
Alere San Diego
Servier
Department of Medicine, Helsinki Univerity Central Hospital, Helsinki, Finland
University Hospital, Basel, Switzerland
Division of Cardiology, Massachusetts General Hospital, Boston, MA
Emergency Medicine Institute, The Cleveland Clinic, Cleveland, Ohio, USA
Maastricht University Medical Center
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria
Cardiology Service, Virgen de la Arrixaca Hospital and Department of Medicine, Murcia, Spain
Emergency Department, University Hospital Monastir, Tunis
Università degli Studi di Brescia
Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan
Brno University Hospital
Faculty of Health Sciences University of Cape Town Observatory, South Africa
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01374880
First received: April 26, 2011
Last updated: August 13, 2013
Last verified: June 2013
  Purpose

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
Heart Failure
Dyspnea
Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Long term cardiovascular mortality [ Time Frame: Prospective at 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Prospective at 12 months ] [ Designated as safety issue: No ]
    We assess cardiac morbidity within 3, 6, and 24 months months after admission

  • Diagnostic value of new biomarkers. [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
    Assess accuracy of new biomarkers to discriminate heart failure from non-heart failure (negative and positive predictive values)


Biospecimen Retention:   Samples Without DNA

Biomarkers assessment in plasma at different times according to the study cohort.


Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting with dyspnea secondary or not to heart failure. Patients with dyspnea, edema, with heart failure, ambulatory or admitted for cardiac decompensation (even with cardiac shock and LVAD) ; or entering a cardiac rehabilitation program, will be prospectively collected.

Patients with valvular disease or with chronic heart failure.

Criteria

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
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: NCT01374880

Contacts
Contact: Alexandre Mebazaa, PHD +33(0)149958071 alexandre.mebazaa@lrb.aphp.fr
Contact: Alain Cohen-Solal, PHD +33(0)149956608 alain.cohen-solal@lrb.aphp.fr

Locations
France
Lariboisiere hospital Recruiting
Paris, Ile de France, France, 75475
Contact: Said Laribi, MD    +33(0)149956445    said.laribi@lrb.aphp.fr   
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
Department of Medicine, Helsinki Univerity Central Hospital, Helsinki, Finland
University Hospital, Basel, Switzerland
Division of Cardiology, Massachusetts General Hospital, Boston, MA
Emergency Medicine Institute, The Cleveland Clinic, Cleveland, Ohio, USA
Maastricht University Medical Center
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria
Cardiology Service, Virgen de la Arrixaca Hospital and Department of Medicine, Murcia, Spain
Emergency Department, University Hospital Monastir, Tunis
Università degli Studi di Brescia
Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan
Brno University Hospital
Faculty of Health Sciences University of Cape Town Observatory, South Africa
Investigators
Study Director: Alain Cohen-Solal, PHD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Additional Information:
No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01374880     History of Changes
Other Study ID Numbers: CNIL number: 910198, Unité 942 INSERM
Study First Received: April 26, 2011
Last Updated: August 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Heart failure
Dyspnea
Heart disease
Pulmonary disease
Natriuretic peptide
Rehabilitation

Additional relevant MeSH terms:
Dyspnea
Heart Diseases
Heart Failure
Lung Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 23, 2014