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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | bbloquant treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta-blocker treatment | Drug | beta-blocker treatment |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe P Lechat, MD, PhD | Hopital Pitie-Salpetriere, Paris, France | Study Director |
| Guillaume Jondeau, MD, PhD | Hopital Ambroise-Pare, Boulogne, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Victor Dupuy | Argenteuil | 95107 | France | |||
| Les Etablissements Hospitaliers du Bessin |
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| Mortality, hospital admission, % of patients with beta-blocker treatment |
| at 3 months |
| Bayeux |
| 14401 |
| France |
| Hôpital Ambroise Paré | Boulogne-Billancourt | 92100 | France |
| Centre Hospitalier Universitaire de Caen | Caen | 14033 | France |
| Hôpital Fontenoy de Chartres | Chartres | 28018 | France |
| Centre Hospitalier de Cholet | Cholet | 49325 | France |
| Hôpital Antoine Béclère | Clamart | 92141 | France |
| Hôpital Beaujon | Clichy | 92118 | France |
| Hôpital de Corbeil | Corbeil | 91106 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| Hôpital du Bocage | Dijon | 21000 | France |
| Hôpital A. Michallon | Grenoble | 38009 | France |
| Centre Hospitalier de Versailles | Le Chesnay | 78157 | France |
| Hôpital Saint-Philibert | Lomme | 59462 | France |
| Hôpital Saint-Joseph Saint-Luc | Lyon | 69007 | France |
| Hôpital de la Timone | Marseille | 13005 | France |
| Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Hôpital René Laënnec | Nantes | 44093 | France |
| Hôpital Pasteur | Nice | 06002 | France |
| Hôpital des Armées du Val de Grâce | Paris | 75005 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Groupe Hospitalier Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Hôpital Saint-Michel | Paris | 75015 | France |
| Centre Hospitalier Universitaire La Milétrie | Poitiers | 86021 | France |
| Centre Hospitalier Regional Dubos | Pontoise | 95301 | France |
| Centre Hospitalier Universitaire Potcaillou | Rennes | 35033 | France |
| Hôpital Charles Nicolle | Rouen | 76031 | France |
| Centre Hospitalier Universitaire Hautepierre | Strasbourg | 67098 | France |
| Hôpital de Rangueil | Toulouse | 31403 | France |
| Hôpital Trousseau | Tours | 37044 | France |
| Hôpital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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