Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Upstream therapy
* Other: Conventional rhythm control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upstream rhythm control<br> | Other: Upstream therapy<br>* Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.<br>|
| Active Comparator: Conventional rhythm control<br> | Other: Conventional rhythm control<br>* Usual care for atrial fibrillation and heart failure according to the present guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |