Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening (BConvinced)
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|ClinicalTrials.gov Identifier: NCT00162565|
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Drug: beta-blocker treatment||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Drug: beta-blocker treatment
- Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. [ Time Frame: at day 3 of hospital admission ]
- Clinical status (evaluation by investigator and autoevaluation by patient) [ Time Frame: at day 8 after hospital admission ]
- BNP change [ Time Frame: between admission, day 3 and day 8 ]
- Mortality, hospital admission, % of patients with beta-blocker treatment [ Time Frame: at 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162565
|Study Director:||Philippe P Lechat, MD, PhD||Hopital Pitie-Salpetriere, Paris, France|
|Principal Investigator:||Guillaume Jondeau, MD, PhD||Hopital Ambroise-Pare, Boulogne, France|