Clinical trial NCT00162565: Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening
Official title: Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Keywords: Heart Failure, Congestive
beta-Adrenergic Blockers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.
timeFrame: at day 3 of hospital admission
Secondary outcomes:
measure: Clinical status (evaluation by investigator and autoevaluation by patient)
timeFrame: at day 8 after hospital admission
measure: BNP change
timeFrame: between admission, day 3 and day 8
measure: Mortality, hospital admission, % of patients with beta-blocker treatment
timeFrame: at 3 months
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Hôpital Victor Dupuy
city: Bayeux
country: France
facility: Les Etablissements Hospitaliers du Bessin
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Chartres
country: France
facility: Hôpital Fontenoy de Chartres
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clichy
country: France
facility: Hôpital Beaujon
city: Corbeil
country: France
facility: Hôpital de Corbeil
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Hôpital du Bocage
city: Grenoble
country: France
facility: Hôpital A. Michallon
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
city: Lomme
country: France
facility: Hôpital Saint-Philibert
city: Lyon
country: France
facility: Hôpital Saint-Joseph Saint-Luc
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Hôpital René Laënnec
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: Hôpital des Armées du Val de Grâce
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Saint-Michel
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire La Milétrie
city: Pontoise
country: France
facility: Centre Hospitalier Regional Dubos
city: Rennes
country: France
facility: Centre Hospitalier Universitaire Potcaillou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire Hautepierre
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Tours
country: France
facility: Hôpital Trousseau
city: Vandoeuvre-les-Nancy
country: France
facility: Hôpital de Brabois
Study officials:
affiliation: Hopital Pitie-Salpetriere, Paris, France
name: Philippe P Lechat, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hopital Ambroise-Pare, Boulogne, France
name: Guillaume Jondeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: