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REBEAT Resynchronisation and Beta-Blocker European Trial

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ClinicalTrials.gov Identifier: NCT00305526
Recruitment Status : Terminated (lack of enrolment)
First Posted : March 22, 2006
Last Update Posted : August 9, 2007
Sponsor:
Information provided by:
Guidant Corporation

Brief Summary:
This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Contak Renewal (CRT-D) Phase 4

Detailed Description:
The purpose of this investigation is to evaluate the effect of CRT combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up-titrated to optimal doses before CRT.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Resynchronisation and Beta-Blocker European Trial
Study Start Date : April 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources




Primary Outcome Measures :
  1. LVEF changes between baseline and 6 months measured by Echocardiography

Secondary Outcome Measures :
  1. increase % of patients with successful uptitration for Betablockers, reduce all cause hospitalizations and all cause mortality, reduce all cause mortality and heart failure hospitalizations, reduce all cause mortality and cardiovascular hospitalizations


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (<25% of optimal dosage).

Exclusion Criteria:

  • chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy

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): NCT00305526


Locations
Italy
Spedali Civili di Brescia
Brescia, Italy, 25100
Istituto clinico Humanitas
Milano, Italy
Switzerland
Cardiocentro Ticino
Lugano, Switzerland
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: Antonio Curnis, MD Spedali Civili di Brescia, Brescia, Italy

ClinicalTrials.gov Identifier: NCT00305526     History of Changes
Other Study ID Numbers: REBEAT 1.5
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: August 9, 2007
Last Verified: August 2007

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