Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening (BConvinced)

May 22, 2009 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95107
        • Hôpital Victor Dupuy
      • Bayeux, France, 14401
        • Les Etablissements Hospitaliers du Bessin
      • Boulogne-Billancourt, France, 92100
        • Hôpital Ambroise Paré
      • Caen, France, 14033
        • Centre Hospitalier Universitaire De Caen
      • Chartres, France, 28018
        • Hôpital Fontenoy de Chartres
      • Cholet, France, 49325
        • Centre Hospitalier de Cholet
      • Clamart, France, 92141
        • Hôpital Antoine Béclère
      • Clichy, France, 92118
        • Hôpital Beaujon
      • Corbeil, France, 91106
        • Hôpital de Corbeil
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Dijon, France, 21000
        • Hôpital du Bocage
      • Grenoble, France, 38009
        • Hôpital A. MICHALLON
      • Le Chesnay, France, 78157
        • Centre Hospitalier de Versailles
      • Lomme, France, 59462
        • Hôpital Saint-Philibert
      • Lyon, France, 69007
        • Hôpital Saint-Joseph Saint-Luc
      • Marseille, France, 13005
        • Hôpital de la timone
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve
      • Nantes, France, 44093
        • Hôpital René Laënnec
      • Nice, France, 06002
        • Hopital Pasteur
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75010
        • Hôpital Lariboisiere
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Paris, France, 75005
        • Hôpital des Armées du Val de Grâce
      • Paris, France, 75015
        • Hôpital Saint-Michel
      • Poitiers, France, 86021
        • Centre hospitalier universitaire La Milétrie
      • Pontoise, France, 95301
        • Centre Hospitalier Regional Dubos
      • Rennes, France, 35033
        • Centre Hospitalier Universitaire Potcaillou
      • Rouen, France, 76031
        • Hôpital Charles Nicolle
      • Strasbourg, France, 67098
        • Centre Hospitalier Universitaire Hautepierre
      • Toulouse, France, 31403
        • Hôpital de Rangueil
      • Tours, France, 37044
        • Hôpital TROUSSEAU
      • Vandoeuvre-les-Nancy, France, 54511
        • Hôpital de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
bbloquant treatment
Drug: beta-blocker treatment
beta-blocker treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.
Time Frame: at day 3 of hospital admission
at day 3 of hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical status (evaluation by investigator and autoevaluation by patient)
Time Frame: at day 8 after hospital admission
at day 8 after hospital admission
BNP change
Time Frame: between admission, day 3 and day 8
between admission, day 3 and day 8
Mortality, hospital admission, % of patients with beta-blocker treatment
Time Frame: at 3 months
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Philippe P Lechat, MD, PhD, Hôpital Pitié-Salpêtrière, Paris, France
  • Principal Investigator: Guillaume Jondeau, MD, PhD, Hopital Ambroise-Pare, Boulogne, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 25, 2009

Last Update Submitted That Met QC Criteria

May 22, 2009

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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