RAte Control Efficacy in Permanent Atrial Fibrillation

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Persistent Atrial Fibrillation

Treatments

Procedure: Strict versus lenient rate control

Study type

Interventional

Funder types

Other

Identifiers

NCT00392613

2003B118

Details and patient eligibility

About

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, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Lenient rate control is defined as a resting heart rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1, 2, 3 months (for titration of rate control drugs) and thereafter yearly.

Full description

Study objectives:

To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity
To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function

Enrollment

500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.