Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Drug: beta-blocker treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bbloquant treatment | Drug: beta-blocker treatment<br>* beta-blocker treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. |  | at day 3 of hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Congestive, beta-Adrenergic Blockers