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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation Chronic; Atrial Fibrillation
• Interventions: Other: Rate control

• Registration Number: NCT04542785
• Lead Sponsor: Holbaek Sygehus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2021-03-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16
• Primary Completion: 2026-03-02
• Study Completion: 2026-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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. If the treating physician deems that the participant is not fit to be randomised into both groups based on an individual assessment. Such a decision will be made before randomisation by the treating physician. This can e.g. be participants dependent on a high ventricular rate to maintain a sufficient cardiac output. Such participants could be participants with heart failure, participants with a hemodynamically significant valve dysfunction, or severely dehydrated participants.
5. Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenient rate control	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.
Strict rate control	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.

Primary Outcome Measures

Name	Time	Method
Short Form-36 (SF-36) physical component score	After 1 year

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Holbæk Hospital; 🇩🇰 Holbæk, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark

Zealand University Hospital - Roskilde; 🇩🇰 Roskilde, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark