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Brain Natriuretic Peptide (BNP) Usefulness In Elderly Dyspneic Patients (BED) (BED)

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ClinicalTrials.gov Identifier: NCT00658216
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Heart Failure

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

Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.
Study Start Date : June 2007
Primary Completion Date : August 2011
Study Completion Date : February 2012
Groups and Cohorts

Group/Cohort
Longitudinal
Prospective study : cohort of consecutive patients recruited over 2 years


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. 2.at T48 : in diagnosing and prognosing HF using a 2nd assay after 48 hours of treatment [ Time Frame: 6 months ]
  3. 3.at Tend : in prognosing HF using a 3rd assay after the acute phase (composite criteria) [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Blood sample for brain natriuretic peptide measurement

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Defined population
Criteria

Inclusion Criteria:

  • acute dyspnea
  • crackles on lung auscultation,
  • hypoxemia,
  • right-sided signs.

Exclusion Criteria:

  • no exclusion criteria
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658216


Locations
France
Broca Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier Hanon, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

Additional Information:
Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00658216     History of Changes
Other Study ID Numbers: SCR 06 007
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: July 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diagnosis and prognosis
Very elderly population
Heart failure
Brain natriuretic peptide
Observational prospective study
Older
Dyspneic patients aged 80

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs