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 number	NCT00392613
Secondary identifying numbers	NTR425

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Isabelle C. Gelder, van
Scientific

University Medical Center Groningen
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3611327
Email	i.c.van.gelder@thorax.umcg.nl

Study information

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	01/01/2005
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

University Medical Center Groningen

Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (Netherlands)
Hospital/treatment centre

Dr Isabelle C. van Gelder
University Medical Center Groningen
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3611327
Email	i.c.van.gelder@thorax.umcg.nl
"ROR"	https://ror.org/03cv38k47

Funders

Funder type

Industry

Dutch Heart Foundation (Nederlandse Hartstichting [NHS]) (Netherlands) (ref: 2003B118)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Heart Foundation
Location: Netherlands

Interuniversity Cardiology Institute (ICIN) (Netherlands)

No information available

Working group on Cardiovascular research (WCN) (Netherlands)

No information available

AstraZeneca
Government organisation / For-profit companies (industry)

Alternative name(s): AstraZeneca PLC, Pearl Therapeutics
Location: United Kingdom

Biotronik

No information available

Guidant

No information available

Medtronic
Private sector organisation / For-profit companies (industry)

Alternative name(s): Medtronic Inc.
Location: United States of America

Vitatron

No information available

Roche
Government organisation / For-profit companies (industry)

Alternative name(s): F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location: Switzerland

Sanofi Aventis (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2006		Yes	No
Results article	results	23/08/2011		Yes	No

Editorial Notes

13/02/2019: Publication reference added.