NCT00162565

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	beta-blocker treatment	beta-blocker treatment

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2005-09-13
• Last updated: 2009-05-25

Locations

32 sites across 1 country: France