REBEAT Resynchronisation and Beta-Blocker European Trial
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Contak Renewal (CRT-D)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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
Sites / Locations
- Spedali Civili di Brescia
- Istituto clinico Humanitas
- Cardiocentro Ticino
Outcomes
Primary Outcome Measures
LVEF changes between baseline and 6 months measured by Echocardiography
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00305526
Brief Title
REBEAT Resynchronisation and Beta-Blocker European Trial
Official Title
Resynchronisation and Beta-Blocker European Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
lack of enrolment
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Guidant Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
354 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Contak Renewal (CRT-D)
Primary Outcome Measure Information:
Title
LVEF changes between baseline and 6 months measured by Echocardiography
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Curnis, MD
Organizational Affiliation
Spedali Civili di Brescia, Brescia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Istituto clinico Humanitas
City
Milano
Country
Italy
Facility Name
Cardiocentro Ticino
City
Lugano
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
REBEAT Resynchronisation and Beta-Blocker European Trial
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