REBEAT Resynchronisation and Beta-Blocker European Trial

Resynchronisation and Beta-Blocker European Trial

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00305526

Enrollment

354

Registered

2006-03-22

Start date

2006-04-30

Completion date

2007-07-31

Last updated

2007-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICEContak Renewal (CRT-D)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
LVEF changes between baseline and 6 months measured by Echocardiography	—

Secondary

Measure	Time frame
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	—

Countries

Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026