Heart Failure, Congestive Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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