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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

• 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).

• Informed consent.

• Adult (18 years or older).

Locations
Other Locations
Denmark
Holbæk Hospital
RECRUITING
Holbæk
Hvidovre University Hospital
NOT_YET_RECRUITING
Hvidovre
Odense University Hospital
NOT_YET_RECRUITING
Odense
Zealand University Hospital - Roskilde
NOT_YET_RECRUITING
Roskilde
Contact Information
Primary
Joshua Feinberg, MD
jorf@regionsjaelland.dk
+45 59484530
Time Frame
Start Date: 2021-03-31
Estimated Completion Date: 2026-03-02
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Holbaek Sygehus
Collaborators: Zealand University Hospital, Odense University Hospital, Hvidovre University Hospital

This content was sourced from clinicaltrials.gov

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