Heart FailureBEDNCT00658216
Brain Natriuretic Peptide (BNP) Usefulness In Elderly Dyspneic Patients (BED)
An observational study of Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 390 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Feb 2012
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Defined population
Who may be able to join
- acute dyspnea
- crackles on lung auscultation,
- hypoxemia,
- right-sided signs.
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.
The purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.
Read the detailed description
Measurement of BNP concentration is approved for use in the diagnosis of heart failure (HF) in elderly patients below 80 years of age. The value of plasma BNP assays as diagnostic tools has not been determined in very elderly populations because the plasma BNP increases with age. This large, multicenter, prospective, observational, study in 300 participants is aimed to prospectively test the usefulness of measuring plasma BNP for diagnosis of HF in dyspneic patients aged 80 and older.
- Conditions
- Heart Failure
- Keywords
- Diagnosis and prognosis, Very elderly population, Heart failure, Brain natriuretic peptide, Observational prospective study, Older, Dyspneic patients aged 80
- Medical subject headings
- Heart Failure, Disease
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 |
|---|---|---|
| Longitudinal | Prospective study : cohort of consecutive patients recruited over 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma BNP levels at T0 to test the optimal values of measuring plasma BNP for diagnosis of HF in patients older than 80 years.
Measured: 6 months
Secondary outcomes (3)
Plasma BNP levels at 3 times (T0, T48, Tend) to test the usefulness of measuring plasma BNP : 1.at T0 : in diagnosing HF using a 2-threshold up-and down-approach
Measured: 6 months
2.at T48 : in diagnosing and prognosing HF using a 2nd assay after 48 hours of treatment
Measured: 6 months
3.at Tend : in prognosing HF using a 3rd assay after the acute phase (composite criteria)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJun 2007
- Primary completionAug 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Assistance Publique - Hôpitaux de ParisThe 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
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658216
- Sponsor's protocol ID
- SCR 06 007
- Acronym
- BED
- Status last verified
- Jul 2013
- First submitted
- 8 Apr 2008
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Komajda M, Hanon O, Aupetit JF, Benetos A, Berrut G, Emeriau JP, Friocourt P, Galinier M, De Groote P, Jondeau G, Jourdain P, Forette F. Management of heart failure in the elderly: recommendations from the French Society of Cardiology (SFC) and the French Society of Gerontology and Geriatrics (SFGG). J Nutr Health Aging. 2006 Sep-Oct;10(5):434-44.
PubMed 17066218
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.
- ClinicalTrials.gov ID
- NCT00658216
- Acronym / sponsor ID
- BED / SCR 06 007
- Conditions
- Heart Failure
- Keywords
- Diagnosis and prognosis, Very elderly population, Heart failure, Brain natriuretic peptide, Observational prospective study, Older, Dyspneic patients aged 80
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 14 Apr 2008 (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 purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.
Detailed description
Measurement of BNP concentration is approved for use in the diagnosis of heart failure (HF) in elderly patients below 80 years of age. The value of plasma BNP assays as diagnostic tools has not been determined in very elderly populations because the plasma BNP increases with age. This large, multicenter, prospective, observational, study in 300 participants is aimed to prospectively test the usefulness of measuring plasma BNP for diagnosis of HF in dyspneic patients aged 80 and older.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal | – | –Prospective study : cohort of consecutive patients recruited over 2 years |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Defined population
Key inclusion criteria (4 listed)
- acute dyspnea
- crackles on lung auscultation,
- hypoxemia,
- right-sided signs.
Key exclusion criteria (1 listed)
- no exclusion criteria
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
Plasma BNP levels at T0 to test the optimal values of measuring plasma BNP for diagnosis of HF in patients older than 80 years.
Time frame: 6 months
3 secondary outcomes
Plasma BNP levels at 3 times (T0, T48, Tend) to test the usefulness of measuring plasma BNP : 1.at T0 : in diagnosing HF using a 2-threshold up-and down-approach
Time frame: 6 months
2.at T48 : in diagnosing and prognosing HF using a 2nd assay after 48 hours of treatment
Time frame: 6 months
3.at Tend : in prognosing HF using a 3rd assay after the acute phase (composite criteria)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
- Background: PubMed 17066218Komajda M, Hanon O, Aupetit JF, Benetos A, Berrut G, Emeriau JP, Friocourt P, Galinier M, De Groote P, Jondeau G, Jourdain P, Forette F. Management of heart failure in the elderly: recommendations from the French Society of Cardiology (SFC) and the French Society of Gerontology and Geriatrics (SFGG). J Nutr Health Aging. 2006 Sep-Oct;10(5):434-44.
- The French Society of Cardiology (SFC)Link provided by the sponsor.
- the French Society of Gerontology and Geriatrics (SFGG).Link provided by the sponsor.
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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.
Olivier Hanon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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, run by Assistance Publique - Hôpitaux de Paris 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 1 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: finished, as of the sponsor's last update on 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma BNP levels at T0 to test the optimal values of measuring plasma BNP for diagnosis of HF in patients older than 80 years. (time frame: 6 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 NCT00658216, which also lists 1 linked publication.
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 5 Aug 2013.