REBEAT Resynchronisation and Beta-Blocker European Trial

August 8, 2007 updated by: Guidant Corporation

Resynchronisation and Beta-Blocker European Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

354

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25100
        • Spedali Civili di Brescia
      • Milano, Italy
        • Istituto Clinico Humanitas
  • Switzerland
      • Lugano, Switzerland
        • Cardiocentro Ticino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
LVEF changes between baseline and 6 months measured by Echocardiography

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guidant Corporation

Investigators

  • Principal Investigator: Antonio Curnis, MD, Spedali Civili di Brescia, Brescia, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 9, 2007

Last Update Submitted That Met QC Criteria

August 8, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBEAT 1.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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