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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00162565 |
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 | Intervention | Phase |
---|---|---|
Heart Failure, Congestive |
Drug: beta-blocker treatment |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED) |
Enrollment: | 180 |
Study Start Date: | November 2004 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
bbloquant treatment
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Drug: beta-blocker treatment
beta-blocker treatment
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Hôpital Ambroise Paré | |
Boulogne-Billancourt, France, 92100 | |
Hôpital Beaujon | |
Clichy, France, 92118 | |
Hôpital Henri Mondor | |
Créteil, France, 94000 | |
Hôpital Lariboisière | |
Paris, France, 75010 | |
Hôpital des Armées du Val de Grâce | |
Paris, France, 75005 | |
Hôpital Victor Dupuy | |
Argenteuil, France, 95107 | |
Centre Hospitalier Regional Dubos | |
Pontoise, France, 95301 | |
Hôpital du Bocage | |
Dijon, France, 21000 | |
Hôpital Charles Nicolle | |
Rouen, France, 76031 | |
Hôpital de la Timone | |
Marseille, France, 13005 | |
Hôpital Saint-Joseph Saint-Luc | |
LYON, France, 69007 | |
Hôpital René Laënnec | |
Nantes, France, 44093 | |
Hôpital de Brabois | |
Vandoeuvre-les-Nancy, France, 54511 | |
Hôpital Saint-Philibert | |
Lomme, France, 59462 | |
Hôpital Trousseau | |
Tours, France, 37044 | |
Hôpital de Rangueil | |
Toulouse, France, 31403 | |
Hôpital de Corbeil | |
Corbeil, France, 91106 | |
Centre Hospitalier de Versailles | |
Le Chesnay, France, 78157 | |
Hôpital Arnaud de Villeneuve | |
Montpellier, France, 34295 | |
Centre Hospitalier Universitaire La Milétrie | |
Poitiers, France, 86021 | |
Centre Hospitalier Universitaire Potcaillou | |
Rennes, France, 35033 | |
Hôpital Fontenoy de Chartres | |
Chartres, France, 28018 | |
Hôpital A. Michallon | |
Grenoble, France, 38009 | |
Groupe Hospitalier Pitié-Salpêtrière | |
Paris, France, 75013 | |
Centre Hospitalier de Cholet | |
Cholet, France, 49325 | |
Hôpital Antoine Béclère | |
Clamart, France, 92141 | |
Centre Hospitalier Universitaire Hautepierre | |
Strasbourg, France, 67098 | |
Centre Hospitalier Universitaire de Caen | |
Caen, France, 14033 | |
Les Etablissements Hospitaliers du Bessin | |
Bayeux, France, 14401 | |
Hôpital Européen Georges Pompidou | |
Paris, France, 75015 | |
Hôpital Saint-Michel | |
Paris, France, 75015 | |
Hôpital Pasteur | |
Nice, France, 06002 |
Study Director: | Philippe P Lechat, MD, PhD | Hopital Pitie-Salpetriere, Paris, France |
Principal Investigator: | Guillaume Jondeau, MD, PhD | Hopital Ambroise-Pare, Boulogne, France |
Responsible Party: | Department Clinical Research of Developpement ( Isabelle. BRINDEL ) |
Study ID Numbers: | P030414 |
Study First Received: | September 9, 2005 |
Last Updated: | May 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00162565 History of Changes |
Health Authority: | France: Ministry of Health |
Heart Failure, Congestive beta-Adrenergic Blockers |
Neurotransmitter Agents Heart Failure Heart Diseases |
Adrenergic Agents Adrenergic beta-Antagonists Adrenergic Antagonists |
Neurotransmitter Agents Heart Failure Heart Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Physiological Effects of Drugs Adrenergic beta-Antagonists Adrenergic Antagonists Cardiovascular Diseases Pharmacologic Actions |