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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Pulmonary Disease; Dyspnea

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Paris, Ile de France, France, 75475
      • Recruiting
      • Lariboisiere Hospital
      • Contact: Said Laribi, MD; Phone Number: +33(0)149956445; Email: said.laribi@lrb.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Dyspnea cohort
Stable chronic heart failure
Valvular heart disease
Ventricular assist device
Cardiac arrest
Cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term cardiovascular mortality	To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.	Prospective at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac hospitalization(s) at 3, 6,12 and 24 months	We assess cardiac morbidity within 3, 6, and 24 months months after admission	Prospective at 12 months
Diagnostic value of new biomarkers.	Assess accuracy of new biomarkers to discriminate heart failure from non-heart failure (negative and positive predictive values)	at day 0

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (ESTIMATE): June 16, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Rehabilitation; Heart failure; Natriuretic peptide; Heart disease; Dyspnea; Pulmonary disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Heart Failure; Heart Diseases; Lung Diseases; Dyspnea
• Other Study ID Numbers: CNIL number: 910198; Unité 942 INSERM (OTHER: CCTIRS number 10.103)