Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening
NCT ID: NCT00162565
Last Updated: 2009-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
180 participants
INTERVENTIONAL
2004-11-30
2009-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
bbloquant treatment
beta-blocker treatment
beta-blocker treatment
Interventions
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beta-blocker treatment
beta-blocker treatment
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction less than 40%
Exclusion Criteria
* Indication to withdraw beta-blocker treatment
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Research of Developpement
Principal Investigators
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Philippe P Lechat, MD, PhD
Role: STUDY_DIRECTOR
Hopital Pitie-Salpetriere, Paris, France
Guillaume Jondeau, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital Ambroise-Pare, Boulogne, France
Locations
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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
Hôpital des Armées du Val de Grâce
Paris, , France
Hôpital Lariboisière
Paris, , France
Groupe Hospitalier Pitié-Salpêtrière
Paris, , France
Hôpital Européen Georges Pompidou
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
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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P030414
Identifier Type: -
Identifier Source: org_study_id
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