REBEAT Resynchronisation and Beta-Blocker European Trial

Phase 4

Terminated

• Conditions: Heart Failure

• Registration Number: NCT00305526
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Study Start: 2006-04
• Study Completion: 2007-07
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-08
• Last Update Posted: 2007-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LVEF changes between baseline and 6 months measured by Echocardiography

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Istituto clinico Humanitas; 🇮🇹 Milano, Italy

Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland