REBEAT Resynchronisation and Beta-Blocker European Trial - Full Text View

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00305526

Purpose

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	Intervention	Phase
Heart Failure	Device: Contak Renewal (CRT-D)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Resynchronisation and Beta-Blocker European Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

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

Estimated Enrollment:	354
Study Start Date:	April 2006
Study Completion Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Study ID Numbers:	REBEAT 1.5
Study First Received:	March 21, 2006
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00305526 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Neurotransmitter Agents
Heart Failure
Heart Diseases

Adrenergic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists

Additional relevant MeSH terms:

Neurotransmitter Agents
Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 24, 2009