RAte Control Efficacy in Permanent Atrial Fibrillation

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation

• Registration Number: NCT00392613
• Lead Sponsor: University Medical Center Groningen

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, 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

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 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

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-10-25
• Study First Submitted QC: 2006-10-25
• Study First Posted: 2006-10-26
• Status Verified: 2007-07
• Primary Completion: 2009-12
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality
Heart failure
Stroke
Bleeding
Syncope
Ventricular tachycardia
PM / ICD implantation
Cardiac arrest
Life-threatening adverse effects of RC drugs

Secondary Outcome Measures

Name	Time	Method
All cause mortality
All cause hospitalizations
Exercise tolerance
LV function and left atrial size
Quality of life
NT-proBNP
Costs
Renal function

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands