Status:
COMPLETED
RAte Control Efficacy in Permanent Atrial Fibrillation
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Netherlands Heart Foundation
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The investigators hypothesis is that in patients with permanent AF lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation...
Detailed Description
Study objectives: 1. To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity 2. To show that lenient rate control is not inferior t...
Eligibility Criteria
Inclusion
- Patients with a current episode of permanent AF \< 12 months.
- Age \</= 80 years.
- Mean resting heart rate \> 80 beats per minute with or without rate control medication
- Oral anticoagulation (or aspirin if no risk factors for thromboembolic complications are present).
Exclusion
- Paroxysmal AF
- Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
- Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission \< 3 months before inclusion.
- Cardiac surgery \< 3 months.
- Any stroke.
- Current or foreseen pacemaker and/ or cardiac resynchronization therapy.
- Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole \> 3 seconds or escape rate \< 40 beats per minute in awake symptom-free patients).
- Untreated hyperthyroidism or \< 3 months euthyroidism.
- Inability to walk or bike.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00392613
Start Date
January 1 2005
Last Update
January 7 2010
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9700RB