Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease
August 13, 2013 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ile de France
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Paris, Ile de France, France, 75475
- Recruiting
- Lariboisière Hospital
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Contact:
- Said Laribi, MD
- Phone Number: +33(0)149956445
- Email: said.laribi@lrb.aphp.fr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Dyspnea cohort
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Stable chronic heart failure
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Valvular heart disease
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Ventricular assist device
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Cardiac arrest
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Cardiac rehabilitation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Long term cardiovascular mortality
Time Frame: Prospective at 12 months
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To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.
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Prospective at 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac hospitalization(s) at 3, 6,12 and 24 months
Time Frame: Prospective at 12 months
|
We assess cardiac morbidity within 3, 6, and 24 months months after admission
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Prospective at 12 months
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Diagnostic value of new biomarkers.
Time Frame: at day 0
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Assess accuracy of new biomarkers to discriminate heart failure from non-heart failure (negative and positive predictive values)
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at day 0
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Alain Cohen-Solal, PHD, Institut National de la Santé Et de la Recherche Médicale, France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNIL number: 910198
- Unité 942 INSERM (OTHER: CCTIRS number 10.103)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.