RAte Control Efficacy in Permanent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392613
• Other study ID #: 2003B118
• Status: Completed
• Phase: N/A
• First received: October 25, 2006
• Last updated: January 6, 2010
• Start date: January 2005

Study information

• Verified date: July 2007
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Strict versus lenient rate control

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Netherlands Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality
Primary	Heart failure
Primary	Stroke
Primary	Bleeding
Primary	Syncope
Primary	Ventricular tachycardia
Primary	PM / ICD implantation
Primary	Cardiac arrest
Primary	Life-threatening adverse effects of RC drugs
Secondary	All cause mortality
Secondary	All cause hospitalizations
Secondary	Exercise tolerance
Secondary	LV function and left atrial size
Secondary	Quality of life
Secondary	NT-proBNP
Secondary	Costs
Secondary	Renal function