RAte Control Efficacy in Permanent Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00392613
First received: October 25, 2006
Last updated: January 6, 2010
Last verified: July 2007
  Purpose

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 Intervention
Persistent Atrial Fibrillation
Procedure: Strict versus lenient rate control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

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

Estimated Enrollment: 500
Study Start Date: January 2005
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392613

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Netherlands Heart Foundation
Investigators
Principal Investigator: Isabelle C Van Gelder, MD University Medical Centre Groningen
  More Information

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00392613     History of Changes
Other Study ID Numbers: 2003B118
Study First Received: October 25, 2006
Last Updated: January 6, 2010
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014