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REBEAT Resynchronisation and Beta-Blocker European Trial

NCT ID: NCT00305526

Last Updated: 2007-08-09

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Contak Renewal (CRT-D)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Antonio Curnis, MD

Role: PRINCIPAL_INVESTIGATOR

Spedali Civili di Brescia, Brescia, Italy

Locations

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Spedali Civili di Brescia

Brescia, , Italy

Site Status

Istituto clinico Humanitas

Milan, , Italy

Site Status

Cardiocentro Ticino

Lugano, , Switzerland

Site Status

Countries

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Italy Switzerland

Other Identifiers

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REBEAT 1.5

Identifier Type: -

Identifier Source: org_study_id