Clinical trial NCT01374880: Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease
Official title: Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Dyspnea
Pulmonary Disease
Keywords: Heart failure
Dyspnea
Heart disease
Pulmonary disease
Natriuretic peptide
Rehabilitation
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: University Paris 7 - Denis Diderot
name: ThermoFisher Scientific Brahms Biomarkers France
name: Hoffmann-La Roche
name: Alere San Diego
name: Servier
name: Helsinki University Central Hospital
name: University Hospital, Basel, Switzerland
name: Massachusetts General Hospital
name: The Cleveland Clinic
name: Maastricht University Medical Center
name: Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria
name: Hospital Universitario Virgen de la Arrixaca
name: University Hospital Monastir, Tunis
name: Università degli Studi di Brescia
name: Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan
name: Brno University Hospital
name: University of Cape Town
First posted: 2011-06-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Long term cardiovascular mortality
timeFrame: Prospective at 12 months
Secondary outcomes:
measure: Cardiac hospitalization(s) at 3, 6,12 and 24 months
timeFrame: Prospective at 12 months
measure: Diagnostic value of new biomarkers.
timeFrame: at day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Lariboisiere hospital
state: Ile de France
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Alain Cohen-Solal, PHD
role: STUDY_DIRECTOR
References:
citation: Badoz M, Arrigo M, Mogenet AC, Sadoune M, Meneveau N, Mebazaa A, Seronde MF. Assessment of successful percutaneous mitral commissurotomy by MRproANP and sCD146. BMC Cardiovasc Disord. 2020 Apr 5;20(1):157. doi: 10.1186/s12872-020-01435-y.
citation: Van Aelst LNL, Abraham M, Sadoune M, Lefebvre T, Manivet P, Logeart D, Launay JM, Karim Z, Puy H, Cohen-Solal A. Iron status and inflammatory biomarkers in patients with acutely decompensated heart failure: early in-hospital phase and 30-day follow-up. Eur J Heart Fail. 2017 Aug;19(8):1075-1076. doi: 10.1002/ejhf.837. Epub 2017 May 17. No abstract available.
citation: Vodovar N, Seronde MF, Laribi S, Gayat E, Lassus J, Boukef R, Nouira S, Manivet P, Samuel JL, Logeart D, Ishihara S, Cohen Solal A, Januzzi JL Jr, Richards AM, Launay JM, Mebazaa A; GREAT Network. Post-translational modifications enhance NT-proBNP and BNP production in acute decompensated heart failure. Eur Heart J. 2014 Dec 21;35(48):3434-41. doi: 10.1093/eurheartj/ehu314. Epub 2014 Aug 24.