NCT00392613

Brief Summary

The investigators hypothesis is that in patients with permanent AF lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Lenient rate control is defined as a resting heart rate \<110 bpm.Strict rate control is defined as a mean resting heart rate \< 80 beats per minute (bpm) and heart rate during minor exercise \< 110 bpm. Patients will be seen after 1, 2, 3 months (for titration of rate control drugs) and thereafter yearly.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

January 7, 2010

Status Verified

July 1, 2007

Enrollment Period

4.9 years

First QC Date

October 25, 2006

Last Update Submit

January 6, 2010

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (9)

  • Cardiovascular mortality

  • Heart failure

  • Stroke

  • Bleeding

  • Syncope

  • Ventricular tachycardia

  • PM / ICD implantation

  • Cardiac arrest

  • Life-threatening adverse effects of RC drugs

Secondary Outcomes (8)

  • All cause mortality

  • All cause hospitalizations

  • Exercise tolerance

  • LV function and left atrial size

  • Quality of life

  • +3 more secondary outcomes

Interventions

Strict versus lenient rate controlPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a current episode of permanent AF \< 12 months.
  • Age \</= 80 years.
  • Mean resting heart rate \> 80 beats per minute with or without rate control medication
  • Oral anticoagulation (or aspirin if no risk factors for thromboembolic complications are present).

You may not qualify if:

  • Paroxysmal AF
  • Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
  • Cardiac surgery \< 3 months.
  • Any stroke.
  • Current or foreseen pacemaker and/ or cardiac resynchronization therapy.
  • Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole \> 3 seconds or escape rate \< 40 beats per minute in awake symptom-free patients).
  • Untreated hyperthyroidism or \< 3 months euthyroidism.
  • Inability to walk or bike.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Related Publications (3)

  • Groenveld HF, Crijns HJ, Van den Berg MP, Van Sonderen E, Alings AM, Tijssen JG, Hillege HL, Tuininga YS, Van Veldhuisen DJ, Ranchor AV, Van Gelder IC; RACE II Investigators. The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study. J Am Coll Cardiol. 2011 Oct 18;58(17):1795-803. doi: 10.1016/j.jacc.2011.06.055.

    PMID: 21996393DERIVED

  • Smit MD, Crijns HJ, Tijssen JG, Hillege HL, Alings M, Tuininga YS, Groenveld HF, Van den Berg MP, Van Veldhuisen DJ, Van Gelder IC; RACE II Investigators. Effect of lenient versus strict rate control on cardiac remodeling in patients with atrial fibrillation data of the RACE II (RAte Control Efficacy in permanent atrial fibrillation II) study. J Am Coll Cardiol. 2011 Aug 23;58(9):942-9. doi: 10.1016/j.jacc.2011.04.030.

    PMID: 21851883DERIVED

  • Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15.

    PMID: 20231232DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabelle C Van Gelder, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2009

Last Updated

January 7, 2010

Record last verified: 2007-07

Locations

NL(1)