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RAte Control Efficacy in Permanent Atrial Fibrillation

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Strict versus lenient rate control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2005
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular mortality
  2. Heart failure
  3. Stroke
  4. Bleeding
  5. Syncope
  6. Ventricular tachycardia
  7. PM / ICD implantation
  8. Cardiac arrest
  9. Life-threatening adverse effects of RC drugs

Secondary Outcome Measures :
  1. All cause mortality
  2. All cause hospitalizations
  3. Exercise tolerance
  4. LV function and left atrial size
  5. Quality of life
  6. NT-proBNP
  7. Costs
  8. Renal function

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392613


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Netherlands Heart Foundation
Investigators
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Principal Investigator: Isabelle C Van Gelder, MD University Medical Center Groningen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00392613    
Other Study ID Numbers: 2003B118
First Posted: October 26, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: July 2007
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes