Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease
This study is currently recruiting participants.
Verified September 2011 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
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
University of Brescia
Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan
Brno University Hospital
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: January 22, 2013
Last verified: September 2011
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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 pronostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 12 months.
Secondary Outcome Measures:
- Cardiac hospitalisation(s) at 12 months [ Time Frame: Prospective at 12 months ] [ Designated as safety issue: No ]We assess cardiac morbidity within 12 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 postive predictitive value)
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: | January 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.
Exclusion Criteria:
- terminal cancer
- progressive neurological disease
- pregnancy
- opposition of the patient
Contacts and Locations
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
University of Brescia
Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan
Brno University Hospital
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: | January 22, 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 Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013