RAte Control Efficacy in Permanent Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT00392613|
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : January 7, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation||Procedure: Strict versus lenient rate control||Not Applicable|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RAte Control Efficacy in Permanent Atrial Fibrillation, a Comparison Between Lenient Versus Strict Rate Control in Patients With and Without Heart Failure.|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2009|
- Cardiovascular mortality
- Heart failure
- Ventricular tachycardia
- PM / ICD implantation
- Cardiac arrest
- Life-threatening adverse effects of RC drugs
- All cause mortality
- All cause hospitalizations
- Exercise tolerance
- LV function and left atrial size
- Quality of life
- Renal function
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392613
|University Medical Center Groningen|
|Groningen, Netherlands, 9700RB|
|Principal Investigator:||Isabelle C Van Gelder, MD||University Medical Center Groningen|
|Other Study ID Numbers:||
|First Posted:||October 26, 2006 Key Record Dates|
|Last Update Posted:||January 7, 2010|
|Last Verified:||July 2007|