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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00658216
First received: April 8, 2008
Last updated: December 15, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Biospecimen Retention:   Samples Without DNA

Blood sample for brain natriuretic peptide measurement


Enrollment: 390
Study Start Date: June 2007
Estimated Study Completion Date: February 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Longitudinal
Prospective study : cohort of consecutive patients recruited over 2 years

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.

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658216

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

Additional Information:
The French Society of Cardiology (SFC)  This link exits the ClinicalTrials.gov site
the French Society of Gerontology and Geriatrics (SFGG).  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00658216     History of Changes
Other Study ID Numbers: SCR 06 007
Study First Received: April 8, 2008
Last Updated: December 15, 2011
Health Authority: France: Ministry of Health

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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013