Contact information
Type
Scientific
Primary contact
Dr Isabelle C. Gelder, van
ORCID ID
Contact details
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3611327
i.c.van.gelder@thorax.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00392613
Protocol/serial number
NTR425
Study information
Scientific title
Acronym
RACE II
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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/01/2005
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
500
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (Netherlands)
Sponsor details
Dr Isabelle C. van Gelder
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3611327
i.c.van.gelder@thorax.umcg.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands) (ref: 2003B118)
Alternative name(s)
Dutch Heart Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
Funder name
Interuniversity Cardiology Institute (ICIN) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Working group on Cardiovascular research (WCN) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AstraZeneca
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
Biotronik
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Guidant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medtronic
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Vitatron
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Switzerland
Funder name
Sanofi Aventis (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16923407
Publication citations
-
Protocol
Van Gelder IC, Van Veldhuisen DJ, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Bosker HA, Cornel JH, Kamp O, Veeger NJ, Volbeda M, Rienstra M, Ranchor AV, TenVergert EM, Van den Berg MP, RAte Control Efficacy in permanent atrial fibrillation: a comparison between lenient versus strict rate control in patients with and without heart failure. Background, aims, and design of RACE II., Am. Heart J., 2006, 152, 3, 420-426, doi: 10.1016/j.ahj.2006.02.033.