RAte Control Efficacy in Permanent Atrial Fibrillation - Full Text View

Sponsor:	University Medical Centre Groningen
Collaborator:	Netherlands Heart Foundation
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00392613

Purpose

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.

Condition	Intervention
Persistent Atrial Fibrillation	Procedure: Strict versus lenient rate control

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	RAte Control Efficacy in Permanent Atrial Fibrillation, a Comparison Between Lenient Versus Strict Rate Control in Patients With and Without Heart Failure.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	500
Study Start Date:	January 2005
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392613

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB

Sponsors and Collaborators

University Medical Centre Groningen

Netherlands Heart Foundation

Investigators

Principal Investigator:

Isabelle C Van Gelder, MD

University Medical Centre Groningen

More Information

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Groenveld HF, Crijns HJ, Van den Berg MP, Van Sonderen E, Alings AM, Tijssen JG, Hillege HL, Tuininga YS, Van Veldhuisen DJ, Ranchor AV, Van Gelder IC; RACE II Investigators. The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study. J Am Coll Cardiol. 2011 Oct 18;58(17):1795-803.

Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. Epub 2010 Mar 15.

ClinicalTrials.gov Identifier:	NCT00392613 History of Changes
Other Study ID Numbers:	2003B118
Study First Received:	October 25, 2006
Last Updated:	January 6, 2010
Health Authority:	European Union: European Medicines Agency

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012