Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2005-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Strict versus lenient rate control
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Netherlands Heart Foundation
OTHER
University Medical Center Groningen
OTHER
Principal Investigators
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Isabelle C Van Gelder, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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References
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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. doi: 10.1016/j.jacc.2011.06.055.
Smit MD, Crijns HJ, Tijssen JG, Hillege HL, Alings M, Tuininga YS, Groenveld HF, Van den Berg MP, Van Veldhuisen DJ, Van Gelder IC; RACE II Investigators. Effect of lenient versus strict rate control on cardiac remodeling in patients with atrial fibrillation data of the RACE II (RAte Control Efficacy in permanent atrial fibrillation II) study. J Am Coll Cardiol. 2011 Aug 23;58(9):942-9. doi: 10.1016/j.jacc.2011.04.030.
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. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15.
Other Identifiers
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2003B118
Identifier Type: -
Identifier Source: org_study_id
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