Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation Randomised Clinical Trial

Overview

Atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. The comparable effects of a lenient rate control strategy and a strict rate control strategy in patients with atrial fibrillation are uncertain and only one trial has assessed this previously in patients with permanent atrial fibrillation. The investigators will therefore undertake a randomised, superiority trial at four hospitals in Denmark.

Full Title of Study: “Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation (DanAF) Randomised Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2, 2026

Interventions

  • Other: Rate control
    • Treatment will be provided according to current guidelines and as such the algorithm for treatment will be differentiated based on the status of left ventricular ejection fraction. For participants with reduced left ventricular ejection fraction, beta-blockers (metoprolol and bisoprolol) will be the primary therapy. Secondary therapies may include digoxin or amiodarone. For participants with preserved left ventricular ejection fraction, the primary therapy will be beta-blockers (metoprolol and bisoprolol) or non-dihydropyridine calcium-channel blockers (verapamil) with secondary therapy consisting of digoxin or amiodarone. Pacing therapies, alone or with atrioventricular node ablation, are utilised as indicated in the view of the treating physician.

Arms, Groups and Cohorts

  • Experimental: Lenient rate control
    • Treating physicians will target a resting heart rate between 80 and 110 beats per minute on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest.
  • Active Comparator: Strict rate control
    • Treating physicians will target a resting heart rate a mean resting heart rate < 80 bpm on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest.

Clinical Trial Outcome Measures

Primary Measures

  • Short Form-36 (SF-36) physical component score
    • Time Frame: After 1 year

Secondary Measures

  • Days alive outside hospital
    • Time Frame: After 6 months
  • Atrial Fibrillation Effect on Quality of Life (AFEQT)
    • Time Frame: After 1 year
  • Short Form-36 (SF-36) mental component score
    • Time Frame: 1 year
  • Serious adverse events
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

1. Participants with atrial fibrillation (ECG confirmed and diagnosed by the treatment provider) who at inclusion have either persistent (defined as atrial fibrillation for more than 7days) or permanent atrial fibrillation (only rate control is considered going forward). 2. Rate control must be accepted as being the primary management strategy going forward. Consideration towards whether rhythm control is more appropriate must be considered, especially given the results of the Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST). 3. Informed consent. 4. Adult (18 years or older). Exclusion Criteria:

1. No informed consent. 2. Initial heart rate under 80 bpm at rest (assessed via ECG before randomisation). 3. Less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated. 4. Participants dependent on a high ventricular rate to maintain a sufficient cardiac output. This will be based on an individual assessment of the possible participant. Such participants could be participants with heart failure, participants with a haemodynamically significant valve dysfunction or severely dehydrated participants. Other factors such as echocardiographic assessments, stability of the disease and similar will be factored in when judging if a participant is dependent on a high ventricular rate. Such a decision will be made before randomisation by the treatment provider. 5. Participants who cannot tolerate a lenient rate control strategy (e.g. in case of tachycardia induced cardiomyopathy). This will be based on an individual assessment of the possible participant. Such a decision will be made before randomisation by the treatment provider. 6. Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Holbaek Sygehus
  • Collaborator
    • Odense University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joshua Rose-Hansen Feinberg, MD – Holbaek Sygehus
  • Overall Official(s)
    • Joshua Feinberg, MD, Principal Investigator, Holbaek University Hospital/University of Southern Denmark
  • Overall Contact(s)
    • Joshua Feinberg, MD, +45 59484530, jorf@regionsjaelland.dk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.