Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening

Heart Failure, Congestive Clinical Trial

— BConvinced  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162565
• Other study ID #: P030414
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: May 22, 2009
• Start date: November 2004
• Est. completion date: February 2009

Study information

• Verified date: August 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• beta-blocker treatment
beta-blocker treatment

Locations

Country	Name	City	State
France	Hôpital Victor Dupuy	Argenteuil
France	Les Etablissements Hospitaliers du Bessin	Bayeux
France	Hôpital Ambroise Paré	Boulogne-Billancourt
France	Centre Hospitalier Universitaire de Caen	Caen
France	Hôpital Fontenoy de Chartres	Chartres
France	Centre Hospitalier de Cholet	Cholet
France	Hôpital Antoine Béclère	Clamart
France	Hôpital Beaujon	Clichy
France	Hôpital de Corbeil	Corbeil
France	Hôpital Henri Mondor	Créteil
France	Hôpital du Bocage	Dijon
France	Hôpital A. Michallon	Grenoble
France	Centre Hospitalier de Versailles	Le Chesnay
France	Hôpital Saint-Philibert	Lomme
France	Hôpital Saint-Joseph Saint-Luc	Lyon
France	Hôpital de la Timone	Marseille
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Hôpital René Laënnec	Nantes
France	Hôpital Pasteur	Nice
France	Groupe Hospitalier Pitié-Salpêtrière	Paris
France	Hôpital des Armées du Val de Grâce	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Saint-Michel	Paris
France	Centre Hospitalier Universitaire La Milétrie	Poitiers
France	Centre Hospitalier Regional Dubos	Pontoise
France	Centre Hospitalier Universitaire Potcaillou	Rennes
France	Hôpital Charles Nicolle	Rouen
France	Centre Hospitalier Universitaire Hautepierre	Strasbourg
France	Hôpital de Rangueil	Toulouse
France	Hôpital Trousseau	Tours
France	Hôpital de Brabois	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.		at day 3 of hospital admission	No
Secondary	Clinical status (evaluation by investigator and autoevaluation by patient)		at day 8 after hospital admission	No
Secondary	BNP change		between admission, day 3 and day 8	No
Secondary	Mortality, hospital admission, % of patients with beta-blocker treatment		at 3 months	No