Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient versus strict rate control in patients with and without heart failure
| ISRCTN | ISRCTN36532482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36532482 |
| ClinicalTrials.gov (NCT) | NCT00392613 |
| Protocol serial number | NTR425 |
| Sponsor | University Medical Center Groningen (UMCG) (Netherlands) |
| Funders | Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands) (ref: 2003B118), Interuniversity Cardiology Institute (ICIN) (Netherlands), Working group on Cardiovascular research (WCN) (Netherlands), AstraZeneca, Biotronik, Guidant, Medtronic, Vitatron, Roche, Sanofi Aventis (France) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 13/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3611327 |
|---|---|
| i.c.van.gelder@thorax.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Rate Control Efficacy in permanent atrial fibrillation, a comparison between lenient versus strict rate control in patients with and without heart failure |
| Study acronym | RACE II |
| Study objectives | 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. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Atrial fibrillation |
| Intervention | 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 |
| Intervention type | Other |
| 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. |
| Key secondary outcome measure(s) |
1. All cause mortality |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
9700 RB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/08/2011 | Yes | No | |
| Protocol article | protocol | 01/09/2006 | Yes | No |
Editorial Notes
13/02/2019: Publication reference added.
