Heart FailureNCT01374880
Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease
An observational study of Heart Failure and Dyspnea, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Dyspnea, Pulmonary Disease
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- terminal cancer
- progressive neurological disease
- pregnancy
- opposition of the patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lariboisiere hospital
Paris, Île-de-France Region, 75475
Said Laribi, MD, +33(0)149956445, said.laribi@lrb.aphp.fr
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Dyspnea, Pulmonary Disease
- Keywords
- Heart failure, Dyspnea, Heart disease, Pulmonary disease, Natriuretic peptide, Rehabilitation
- Medical subject headings
- Heart Failure, Dyspnea, Lung Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term cardiovascular mortality
To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.
Measured: Prospective at 12 months
Secondary outcomes (2)
Cardiac hospitalization(s) at 3, 6,12 and 24 months
We assess cardiac morbidity within 3, 6, and 24 months months after admission
Measured: 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)
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJun 2009
- Primary completionSep 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, University Paris 7 - Denis Diderot, ThermoFisher Scientific Brahms Biomarkers France, Hoffmann-La Roche, Alere San Diego, Servier, Helsinki University Central Hospital, University Hospital, Basel, Switzerland, Massachusetts General Hospital, The Cleveland Clinic, Maastricht University Medical Center, Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria, Hospital Universitario Virgen de la Arrixaca, University Hospital Monastir, Tunis, Università degli Studi di Brescia, Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan, Brno University Hospital, University of Cape Town
- Responsible party
- Sponsor
- Investigators
- Alain Cohen-Solal, PHD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374880
- Sponsor's protocol ID
- CNIL number: 910198
- Other IDs
- Unité 942 INSERM
- Status last verified
- Jun 2013
- First submitted
- 26 Apr 2011
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32248819Van 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.
PubMed 28516737Vodovar 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.
PubMed 25157115
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease
- ClinicalTrials.gov ID
- NCT01374880
- Acronym / sponsor ID
- CNIL number: 910198
- Conditions
- Heart Failure, Dyspnea, Pulmonary Disease
- Keywords
- Heart failure, Dyspnea, Heart disease, Pulmonary disease, Natriuretic peptide, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Assistance Publique - Hôpitaux de Paris, University Paris 7 - Denis Diderot, ThermoFisher Scientific Brahms Biomarkers France, Hoffmann-La Roche, Alere San Diego, Servier, Helsinki University Central Hospital, University Hospital, Basel, Switzerland, Massachusetts General Hospital, The Cleveland Clinic, Maastricht University Medical Center, Department of Laboratory Medicine, Konventhospital Barmherzige Brueder, Linz, Austria, Hospital Universitario Virgen de la Arrixaca, University Hospital Monastir, Tunis, Università degli Studi di Brescia, Intensive and Cardiac Care Unit, Nippon Medical School, Tokyo, Japan, Brno University Hospital, University of Cape Town
- Study start
- Jun 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- terminal cancer
- progressive neurological disease
- pregnancy
- opposition of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long term cardiovascular mortality
Time frame: Prospective at 12 months
To detect prognostic values of plasma biomarkers, we assess cardiovascular mortality at 3, 6, and 24 months.
2 secondary outcomes
Cardiac hospitalization(s) at 3, 6,12 and 24 months
Time frame: Prospective at 12 months
Diagnostic value of new biomarkers.
Time frame: at day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Derived from this study: PubMed 32248819Badoz 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.
- Derived from this study: PubMed 28516737Van 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.
- Derived from this study: PubMed 25157115Vodovar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Cohen-Solal, PHD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Dyspnea, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Mebazaa, PHD (+33(0)149958071, alexandre.mebazaa@lrb.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term cardiovascular mortality (time frame: Prospective at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374880, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.