Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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)

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

Results - basic reporting

Publication summary

2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16923407

Publication citations

  1. 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.

Additional files

Editorial Notes