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

• 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 (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 ]
  

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.