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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162565
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 25, 2009
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: beta-blocker treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : November 2004
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162565


Locations
Show Show 32 study locations
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Philippe P Lechat, MD, PhD Hopital Pitie-Salpetriere, Paris, France
Principal Investigator: Guillaume Jondeau, MD, PhD Hopital Ambroise-Pare, Boulogne, France
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Responsible Party: Isabelle. BRINDEL, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00162565    
Other Study ID Numbers: P030414
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: August 2005
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart Failure, Congestive
beta-Adrenergic Blockers
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs