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

• Conditions: Pulmonary Disease; Heart Failure; Dyspnea

• Registration Number: NCT01374880
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Status Verified: 2013-06
• Last Update Submitted: 2013-08-13
• Last Update Posted: 2013-08-14
• Primary Completion: 2013-09
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Lariboisiere hospital; 🇫🇷 Paris, Ile de France, France