Heart Failure, Congestive
Conditions
Keywords
Heart Failure, Congestive, beta-Adrenergic Blockers
Brief 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.
Interventions
DRUGbeta-blocker treatment
beta-blocker treatment
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. | at day 3 of hospital admission |
Secondary
| Measure | Time frame |
|---|---|
| Clinical status (evaluation by investigator and autoevaluation by patient) | at day 8 after hospital admission |
| BNP change | between admission, day 3 and day 8 |
| Mortality, hospital admission, % of patients with beta-blocker treatment | at 3 months |
Countries
France
Outcome results
None listed