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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01374880
Enrollment
3000
Registered
2011-06-16
Start date
2009-06-30
Completion date
2014-01-31
Last updated
2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Heart Failure, Pulmonary Disease

Keywords

Heart failure, Dyspnea, Heart disease, Pulmonary disease, Natriuretic peptide, Rehabilitation

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Long term cardiovascular mortalityProspective at 12 monthsTo detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.

Secondary

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

Countries

France

Contacts

Primary ContactAlexandre Mebazaa, PHD
alexandre.mebazaa@lrb.aphp.fr+33(0)149958071
Backup ContactAlain Cohen-Solal, PHD
alain.cohen-solal@lrb.aphp.fr+33(0)149956608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026