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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00162565
First received: September 9, 2005
Last updated: May 22, 2009
Last verified: August 2005
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion. [ Time Frame: at day 3 of hospital admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical status (evaluation by investigator and autoevaluation by patient) [ Time Frame: at day 8 after hospital admission ] [ Designated as safety issue: No ]
  • BNP change [ Time Frame: between admission, day 3 and day 8 ] [ Designated as safety issue: No ]
  • Mortality, hospital admission, % of patients with beta-blocker treatment [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

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
Experimental: 1
bbloquant treatment
Drug: beta-blocker treatment
beta-blocker treatment
Other Name: beta-blocker 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162565

Locations
France
Hôpital Victor Dupuy
Argenteuil, France, 95107
Les Etablissements Hospitaliers du Bessin
Bayeux, France, 14401
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92100
Centre Hospitalier Universitaire de Caen
Caen, France, 14033
Hôpital Fontenoy de Chartres
Chartres, France, 28018
Centre Hospitalier de Cholet
Cholet, France, 49325
Hôpital Antoine Béclère
Clamart, France, 92141
Hôpital Beaujon
Clichy, France, 92118
Hôpital de Corbeil
Corbeil, France, 91106
Hôpital Henri Mondor
Créteil, France, 94000
Hôpital du Bocage
Dijon, France, 21000
Hôpital A. Michallon
Grenoble, France, 38009
Centre Hospitalier de Versailles
Le Chesnay, France, 78157
Hôpital Saint-Philibert
Lomme, France, 59462
Hôpital Saint-Joseph Saint-Luc
Lyon, France, 69007
Hôpital de la Timone
Marseille, France, 13005
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Hôpital René Laënnec
Nantes, France, 44093
Hôpital Pasteur
Nice, France, 06002
Hôpital Lariboisière
Paris, France, 75010
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital des Armées du Val de Grâce
Paris, France, 75005
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Hôpital Saint-Michel
Paris, France, 75015
Centre Hospitalier Universitaire La Milétrie
Poitiers, France, 86021
Centre Hospitalier Regional Dubos
Pontoise, France, 95301
Centre Hospitalier Universitaire Potcaillou
Rennes, France, 35033
Hôpital Charles Nicolle
Rouen, France, 76031
Centre Hospitalier Universitaire Hautepierre
Strasbourg, France, 67098
Hôpital de Rangueil
Toulouse, France, 31403
Hôpital Trousseau
Tours, France, 37044
Hôpital de Brabois
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Philippe P Lechat, MD, PhD Hopital Pitie-Salpetriere, Paris, France
Principal Investigator: Guillaume Jondeau, MD, PhD Hopital Ambroise-Pare, Boulogne, France
  More Information

No publications provided

Responsible Party: Isabelle. BRINDEL, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00162565     History of Changes
Other Study ID Numbers: P030414
Study First Received: September 9, 2005
Last Updated: May 22, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart Failure, Congestive
beta-Adrenergic Blockers

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Adrenergic beta-Antagonists
Adrenergic Agents
Adrenergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014