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| [ ...Back to search results ] | [ Print-friendly version ] |
| Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient versus strict rate control in patients with and without heart failure |
| ISRCTN | ISRCTN36532482 |
| ClinicalTrials.gov identifier | NCT00392613 |
| Public title | Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient versus strict rate control in patients with and without heart failure |
| Scientific title | |
| Acronym | RACE II |
| Serial number at source | NTR425 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | Received from local medical ethics committee |
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Atrial fibrillation |
| Participants - inclusion criteria |
1. Patients with persistent AF <12 months
2. Age <80 years 3. Resting heart rate >80 beats per minute 4. On oral anticoagulation |
| Participants - exclusion criteria |
1. 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 |
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 01/01/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 500 |
| Interventions |
1. 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 outcome measure(s) | Component 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 outcome measure(s) |
1. All cause 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 |
| Sources of funding |
1. Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands) (ref: 2003B118)
2. Interuniversity Cardiology Institute (ICIN) (Netherlands) 3. Working group on Cardiovascular research (WCN) (Netherlands) 4. AstraZeneca 5. Biotronik 6. Guidant 7. Medtronic 8. Vitatron 9. Roche 10. Sanofi Aventis (France) |
| Trial website | |
| Publications | 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16923407 |
| Contact name | Dr Isabelle C. Gelder, van |
| Address |
University Medical Center Groningen
P.O. Box 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Tel | +31 (0)50 3611327 |
| Fax | +31 (0)50 3614391 |
| i.c.van.gelder@thorax.umcg.nl | |
| Sponsor | University Medical Center Groningen (UMCG) (Netherlands) |
| Address |
Dr Isabelle C. van Gelder
University Medical Center Groningen P.O. Box 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Tel | +31 (0)50 3611327 |
| Fax | +31 (0)50 3614391 |
| i.c.van.gelder@thorax.umcg.nl | |
| Date applied | 27/01/2006 |
| Last edited | 14/08/2009 |
| Date ISRCTN assigned | 27/01/2006 |
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