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

I.C. Van Gelder250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (20)

Ziekenhuisgroep Twente

Almelo, Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Hospital Rijnstate

Arnhem, Netherlands

Ter Gooi Hospital

Blaricum, Netherlands

Amhia Hospital

Breda, Netherlands

Ommelander Hospital Group

Delfzijl, Netherlands

Deventer Hospital

Deventer, Netherlands

Oosterscheldeziekenhuis

Goes, Netherlands

Martini Hospital

Groningen, Netherlands

University Medical Center Groningen

Groningen, Netherlands

...and 10 more locations

Outcomes

Primary Outcomes

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

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