Atrial Fibrillation
Conditions
Brief 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.
Interventions
OTHERUpstream therapy
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
OTHERConventional rhythm control
Usual care for atrial fibrillation and heart failure according to the present guidelines
Sponsors
The Interuniversity Cardiology Institute of the Netherlands
Netherlands Heart Foundation
Dutch Network for Cardiovascular Research
Trial Coordination Center UMC Groningen
Bayer
Boehringer Ingelheim
Medtronic
Biotronik SE & Co. KG
Abbott Medical Devices
Boston Scientific Corporation
AstraZeneca
I.C. Van Gelder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 year after electrical cardioversion |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies. | 5 years after electrical cardioversion |
Countries
Netherlands, United Kingdom
Outcome results
None listed