RAte Control Efficacy in Permanent Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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RAte Control Efficacy in Permanent Atrial Fibrillation, a Comparison Between Lenient Versus Strict Rate Control in Patients With and Without Heart Failure.

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Strict versus lenient rate control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Procedure: Strict versus lenient rate control|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  |  | 
| Heart failure |  |  | 
| Stroke |  |  | 
| Bleeding |  |  | 
| Syncope |  |  | 
| Ventricular tachycardia |  |  | 
| PM / ICD implantation |  |  | 
| Cardiac arrest |  |  | 
| Life-threatening adverse effects of RC drugs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  |  | 
| All cause hospitalizations |  |  | 
| Exercise tolerance |  |  | 
| LV function and left atrial size |  |  | 
| Quality of life |  |  | 
| NT-proBNP |  |  | 
| Costs |  |  | 
| Renal function |  |  |