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RAte Control Efficacy in Permanent Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392613
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : January 7, 2010
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by:
University Medical Center Groningen

Tracking Information
First Submitted Date  ICMJE October 25, 2006
First Posted Date  ICMJE October 26, 2006
Last Update Posted Date January 7, 2010
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
  • Cardiovascular mortality
  • Heart failure
  • Stroke
  • Bleeding
  • Syncope
  • Ventricular tachycardia
  • PM / ICD implantation
  • Cardiac arrest
  • Life-threatening adverse effects of RC drugs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2006)
  • All cause mortality
  • All cause hospitalizations
  • Exercise tolerance
  • LV function and left atrial size
  • Quality of life
  • NT-proBNP
  • Costs
  • Renal function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAte Control Efficacy in Permanent Atrial Fibrillation
Official Title  ICMJE RAte Control Efficacy in Permanent Atrial Fibrillation, a Comparison Between Lenient Versus Strict Rate Control in Patients With and Without Heart Failure.
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:

  1. To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity
  2. 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE Procedure: Strict versus lenient rate control
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 25, 2006)
500
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00392613
Other Study ID Numbers  ICMJE 2003B118
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Medical Center Groningen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Netherlands Heart Foundation
Investigators  ICMJE
Principal Investigator: Isabelle C Van Gelder, MD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP