NCT01374880

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 14, 2013

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

April 26, 2011

Last Update Submit

August 13, 2013

Conditions

Heart FailureDyspneaPulmonary Disease

Keywords

Heart failureDyspneaHeart diseasePulmonary diseaseNatriuretic peptideRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cardiac hospitalization(s) at 3, 6,12 and 24 months

    Prospective at 12 months

  • Diagnostic value of new biomarkers.

    at day 0

Study Arms (6)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • terminal cancer
  • progressive neurological disease
  • pregnancy
  • opposition of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lariboisiere hospital

Paris, Île-de-France Region, 75475, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32248819DERIVED

  • 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.

    PMID: 28516737DERIVED

  • 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.

    PMID: 25157115DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers assessment in plasma at different times according to the study cohort.

MeSH Terms

Conditions

Heart FailureDyspneaLung DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alain Cohen-Solal, PHD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

Central Study Contacts

Alexandre Mebazaa, PHD

CONTACT

+33(0)149958071alexandre.mebazaa@lrb.aphp.fr

Alain Cohen-Solal, PHD

CONTACT

+33(0)149956608alain.cohen-solal@lrb.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

June 16, 2011

Study Start

June 1, 2009

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

August 14, 2013

Record last verified: 2013-06

Locations

FR(1)