NCT00392613

RAte Control Efficacy in Permanent Atrial Fibrillation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Strict versus lenient rate control

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-12-01
• First posted: 2006-10-26
• Last updated: 2010-01-07

Locations

1 site across 1 country: Netherlands