Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening
- Conditions
- Heart Failure, Congestive
- Interventions
- Drug: beta-blocker treatment
- Registration Number
- NCT00162565
- Lead Sponsor
- Assistance Publique - H么pitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
- Left ventricular ejection fraction less than 40%
- Indication of intravenous positive inotropic treatment
- Indication to withdraw beta-blocker treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 beta-blocker treatment bbloquant treatment
- Primary Outcome Measures
Name Time Method Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. at day 3 of hospital admission
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (32)
Centre Hospitalier Universitaire de Caen
馃嚝馃嚪Caen, France
H么pital Victor Dupuy
馃嚝馃嚪Argenteuil, France
H么pital A. Michallon
馃嚝馃嚪Grenoble, France
H么pital Saint-Philibert
馃嚝馃嚪Lomme, France
H么pital Saint-Joseph Saint-Luc
馃嚝馃嚪Lyon, France
Centre Hospitalier Regional Dubos
馃嚝馃嚪Pontoise, France
H么pital Charles Nicolle
馃嚝馃嚪Rouen, France
Centre Hospitalier Universitaire Hautepierre
馃嚝馃嚪Strasbourg, France
H么pital Antoine B茅cl猫re
馃嚝馃嚪Clamart, France
H么pital de Corbeil
馃嚝馃嚪Corbeil, France
Les Etablissements Hospitaliers du Bessin
馃嚝馃嚪Bayeux, France
H么pital de la Timone
馃嚝馃嚪Marseille, France
Centre Hospitalier Universitaire Potcaillou
馃嚝馃嚪Rennes, France
H么pital Europ茅en Georges Pompidou
馃嚝馃嚪Paris, France
Centre Hospitalier de Cholet
馃嚝馃嚪Cholet, France
H么pital Henri Mondor
馃嚝馃嚪Cr茅teil, France
Centre Hospitalier de Versailles
馃嚝馃嚪Le Chesnay, France
H么pital Ambroise Par茅
馃嚝馃嚪Boulogne-Billancourt, France
H么pital du Bocage
馃嚝馃嚪Dijon, France
H么pital Trousseau
馃嚝馃嚪Tours, France
H么pital Fontenoy de Chartres
馃嚝馃嚪Chartres, France
H么pital Arnaud de Villeneuve
馃嚝馃嚪Montpellier, France
Centre Hospitalier Universitaire La Mil茅trie
馃嚝馃嚪Poitiers, France
H么pital de Brabois
馃嚝馃嚪Vandoeuvre-les-Nancy, France
H么pital des Arm茅es du Val de Gr芒ce
馃嚝馃嚪Paris, France
H么pital Lariboisi猫re
馃嚝馃嚪Paris, France
H么pital Beaujon
馃嚝馃嚪Clichy, France
H么pital Ren茅 La毛nnec
馃嚝馃嚪Nantes, France
Groupe Hospitalier Piti茅-Salp锚tri猫re
馃嚝馃嚪Paris, France
H么pital Pasteur
馃嚝馃嚪Nice, France
H么pital Saint-Michel
馃嚝馃嚪Paris, France
H么pital de Rangueil
馃嚝馃嚪Toulouse, France