Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening (BConvinced)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00162565
First received: September 9, 2005
Last updated: May 22, 2009
Last verified: August 2005

September 9, 2005
May 22, 2009
November 2004
February 2009   (final data collection date for primary outcome measure)
Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. [ Time Frame: at day 3 of hospital admission ] [ Designated as safety issue: No ]
Clinical status at day 3 of hospital admission (questionnaire) : the % of patients with clinical improvement is the primary endpoint criteria.
Complete list of historical versions of study NCT00162565 on ClinicalTrials.gov Archive Site
  • Clinical status (evaluation by investigator and autoevaluation by patient) [ Time Frame: at day 8 after hospital admission ] [ Designated as safety issue: No ]
  • BNP change [ Time Frame: between admission, day 3 and day 8 ] [ Designated as safety issue: No ]
  • Mortality, hospital admission, % of patients with beta-blocker treatment [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
clinical status at day 8 after hospital admission (evaluation by investigator and autoevaluation by patient), BNP change between admission, day 3 and day 8. At 3 months : mortality, hospital admission , % of patients with beta-blocker treatment
Not Provided
Not Provided
 
Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening
Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)

The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.

162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear. The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment.

Hypothesis: The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema.

Design: Open, randomized non-inferiority trial on two parallel groups of patients. Randomization performed centrally with a vocal server.

Tested Hypothesis: 90% of success in the interruption group, power of 80%, non-inferiority limit of 15% (relative reduction). 162 patients are required with such a hypothesis.

Primary Endpoint: Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire.

Secondary Endpoints: Clinical improvement at day 8 or at hospital discharge, morbidity-mortality at 4 months.

34 participating centres in France.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: beta-blocker treatment
beta-blocker treatment
Other Name: beta-blocker treatment
Experimental: 1
bbloquant treatment
Intervention: Drug: beta-blocker treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
  • Left ventricular ejection fraction less than 40%

Exclusion Criteria:

  • Indication of intravenous positive inotropic treatment
  • Indication to withdraw beta-blocker treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00162565
P030414
Yes
Isabelle. BRINDEL, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Director: Philippe P Lechat, MD, PhD Hopital Pitie-Salpetriere, Paris, France
Principal Investigator: Guillaume Jondeau, MD, PhD Hopital Ambroise-Pare, Boulogne, France
Assistance Publique - Hôpitaux de Paris
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP