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Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient verus strict rate control in patients with and without heart failure.


- candidate number1730
- NTR NumberNTR425
- ISRCTNISRCTN36532482
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR25-sep-2005
- Secondary IDsN/A 
- Public TitleRate Control Efficacy in permanent atrial fibrillation, a comparison between lenient verus strict rate control in patients with and without heart failure.
- Scientific TitleRate Control Efficacy in permanent atrial fibrillation, a comparison between lenient verus strict rate control in patients with and without heart failure.
- ACRONYMRACE II
- hypothesisLenient rate control is not inferior to strict rate control in patients with permanent atrial fibrillation with and without heart failure in terms of cardiovascular mortality and morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs.
- Healt Condition(s) or Problem(s) studiedHeart failure
- Inclusion criteria1. Patients with persistent AF < 12 months; 2. Age < 80 years; 3. Resting heart rate > 80 beats per minute; 4. On oral anticoagulation.
- Exclusion criteria1. Paroxysmal AF; 2. Known contraindications for strict or lenient rate control; 3. Unstable heart failure; 4. Cardiac surgery. 5. Any current stroke; 6. Foreseen pacemaker or cardiac resynchronization therapy; 7. Sick sinus syndrome or AV node conduction disturbances; 8. Untreated hyperthyroidism; 9. Inability to walk or bike.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate1-jan-2009
- Target number of participants500
- Interventions1. Lenient rate control (heart rate in rest < 110 bpm); 2. Strict rate control: heart rate in rest < 80 bpm and during minor exercise < 110 bpm.
- Primary outcomeComponent of: cardiovascular mortality, heart failure, stroke, systemic emboli, bleeding, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, life-threatening adverse effects of rate control drugs, pacemaker implantation.
- Secondary outcome1. All casue mortality; 2. All cause hospitalizations; 3. Exercise tolerance (NYHA class); 4. Left ventricular function; 5. Left atrial size; 6. Quality of life; 7. NT-proBNP; 8. Hospitalization for heart failure; 9. Syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations; 10. Bleeding, any stroke, systemic emboli; 11. Myocardial infarction confirmed by ECG and enzyme increase; 12. Costs; 13. Renal function.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. Isabelle C. Gelder, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Isabelle C. Gelder, van
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting), Interuniversity Institute of Cardiology (ICIN), The Netherlands, AstraZeneca, Sanofi-Aventis, Roche Nederland BV, Medtronic BV., Guidant Inc, Working group on Cardiovascular research (WCN), the Netherlands, Biotronik, Vitatron
- PublicationsN/A
- Brief summaryRate control may now be adopted as first choice therapy in a variety of patients, especially those with minor symptoms. At present, it still remains unknown whether a strict rate control strategy is associated with an improved prognosis in terms of mortality and morbidity. Our hyopthesis is that lenient rate control is not inferior to strict rate control in patients with permanent atrial fibrillation with and without heart failure in terms of cardiovascular mortality and morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Therefore, we will include 500 patients with permanent AF and randomize the patients to 1. lenient rate control (heart rate in rest < 110 bpm) or 2. strict rate control: heart rate in rest < 80 bpm and during minor exercise < 110 bpm. Follow up will be between 2 and 3 years. At present 28 centers have included 212 patients.
- Main changes (audit trail)
- RECORD25-sep-2005 - 7-mrt-2006


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