search
Back to results

RAte Control Efficacy in Permanent Atrial Fibrillation

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Strict versus lenient rate control
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Paroxysmal AF
  • Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
  • Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission < 3 months before inclusion.
  • 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.

Sites / Locations

  • University Medical Center Groningen

Outcomes

Primary Outcome Measures

Cardiovascular mortality
Heart failure
Stroke
Bleeding
Syncope
Ventricular tachycardia
PM / ICD implantation
Cardiac arrest
Life-threatening adverse effects of RC drugs

Secondary Outcome Measures

All cause mortality
All cause hospitalizations
Exercise tolerance
LV function and left atrial size
Quality of life
NT-proBNP
Costs
Renal function

Full Information

First Posted
October 25, 2006
Last Updated
January 6, 2010
Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00392613
Brief Title
RAte Control Efficacy in Permanent Atrial Fibrillation
Official Title
RAte Control Efficacy in Permanent Atrial Fibrillation, a Comparison Between Lenient Versus Strict Rate Control in Patients With and Without Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Medical Center Groningen
Collaborators
Netherlands Heart Foundation

4. Oversight

5. Study Description

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.
Detailed Description
Study objectives: To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Strict versus lenient rate control
Primary Outcome Measure Information:
Title
Cardiovascular mortality
Title
Heart failure
Title
Stroke
Title
Bleeding
Title
Syncope
Title
Ventricular tachycardia
Title
PM / ICD implantation
Title
Cardiac arrest
Title
Life-threatening adverse effects of RC drugs
Secondary Outcome Measure Information:
Title
All cause mortality
Title
All cause hospitalizations
Title
Exercise tolerance
Title
LV function and left atrial size
Title
Quality of life
Title
NT-proBNP
Title
Costs
Title
Renal function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Paroxysmal AF Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs). Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission < 3 months before inclusion. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle C Van Gelder, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21996393
Citation
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.
Results Reference
derived
PubMed Identifier
21851883
Citation
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.
Results Reference
derived
PubMed Identifier
20231232
Citation
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.
Results Reference
derived

Learn more about this trial

RAte Control Efficacy in Permanent Atrial Fibrillation

We'll reach out to this number within 24 hrs