Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure (RACE 3)

I

I.C. Van Gelder

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: Upstream therapy
Other: Conventional rhythm control

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00877643
NHS B 2008 035

Details and patient eligibility

About

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.

Enrollment

250 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Upstream rhythm control
Experimental group
Treatment:
Other: Upstream therapy
Conventional rhythm control
Active Comparator group
Treatment:
Other: Conventional rhythm control

Trial contacts and locations

20

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems