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Studies

Interventional Recruiting

NCT04542785 on ClinicalTrials.gov

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

Official title: Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation (DanAF) Randomised Clinical Trial

  • Sponsor: Holbæk Sygehus
  • Collaborators: Odense University Hospital, Hvidovre University Hospital, Zealand University Hospital
  • Enrollment: 350 (Estimated)
  • Study start: 2021-03-31 (Actual)
  • Primary completion: 2026-03-02 (Estimated)
  • Study completion: 2026-03-02 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Participant, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Atrial Fibrillation, Persistent
  • Atrial Fibrillation Chronic
  • Atrial Fibrillation

Intervention / Treatment

  • Other: Rate control

Primary Outcome Measures

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

Countries

Denmark

Locations and Investigators

  • Holbæk Hospital, Holbæk, Denmark (Recruiting)
    • Joshua B Feinberg, MD
    • Ilan Raymond, MD (Principal Investigator)
  • Hvidovre University Hospital, Hvidovre, Denmark (Not yet recruiting)
    • Ulrik Dixen, Prof (Principal Investigator)
  • Odense University Hospital, Odense, Denmark (Not yet recruiting)
    • Axel Brandes, prof. (Principal Investigator)
  • Zealand University Hospital - Roskilde, Roskilde, Denmark (Not yet recruiting)
    • Ole D Pedersen, DMSc (Principal Investigator)
    • Uffe Gang, MD

Study Officials