Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments upstream therapy, conventional rhythm control
Sponsor I.C. Van Gelder
Collaborator The Interuniversity Cardiology Institute of the Netherlands
Start date May 2009
End date January 2017
Trial size 250 participants
Trial identifier NCT00877643, NHS B 2008 035

Summary

The purpose of this study is to investigate whether in patients with early persistent atrial fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control approach, including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm compared with conventional rhythm control after one year of follow-up.

A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5 years to investigate the long term effects on persistence of sinus rhythm and cardiovascular morbidity and mortality of the two treatment strategies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
upstream therapy
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
(Active Comparator)
conventional rhythm control
Usual care for atrial fibrillation and heart failure according to the present guidelines

Primary Outcomes

Measure
Success of rhythm control strategy consisting of 1) the patient is still in a rhythm control strategy according to the attending physician, and 2) that sinus rhythm is maintained after 1 year of follow-up.
time frame: 1 year after electrical cardioversion

Secondary Outcomes

Measure
Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies.
time frame: 5 years after electrical cardioversion

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Early symptomatic persistent atrial fibrillation - Mild to moderate early heart failure - Optimal documentation and treatment of underlying heart disease - No contra-indication for oral anticoagulation - Eligible for cardiovascular rehabilitation - Age >= 40 years Exclusion Criteria: - On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year - Heart failure NYHA class IV - LVEF < 25% - Left atrial size > 50 mm (parasternal axis) - Present aldosterone receptor antagonist use - Previous use of class I or III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with betablocker) - Cardiac resynchronization therapy

Additional Information

Official title Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3
Principal investigator Marco Alings, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Medical Center Groningen.