NCT00658216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 5, 2013

Status Verified

July 1, 2013

Enrollment Period

4.2 years

First QC Date

April 8, 2008

Last Update Submit

August 2, 2013

Conditions

Heart Failure

Keywords

Diagnosis and prognosisVery elderly populationHeart failureBrain natriuretic peptideObservational prospective studyOlderDyspneic patients aged 80

Outcome Measures

Primary Outcomes (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.

    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

    6 months

  • 2.at T48 : in diagnosing and prognosing HF using a 2nd assay after 48 hours of treatment

    6 months

  • 3.at Tend : in prognosing HF using a 3rd assay after the acute phase (composite criteria)

    6 months

Study Arms (1)

Longitudinal

Prospective study : cohort of consecutive patients recruited over 2 years

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Defined population

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Broca Hospital

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 17066218BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for brain natriuretic peptide measurement

MeSH Terms

Conditions

Heart FailureDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Hanon, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

June 1, 2007

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

August 5, 2013

Record last verified: 2013-07

Locations

FR(1)