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

NCT04542785 | Recruiting DMC

• 1 other identifier: REG-078-2019
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

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

Keywords

Rate control

Outcome Measures

Primary Outcomes (1)

• Short Form-36 (SF-36) physical component score

  After 1 year

Secondary Outcomes (4)

• Days alive outside hospital

  After 6 months

• Atrial Fibrillation Effect on Quality of Life (AFEQT)

  After 1 year

• Short Form-36 (SF-36) mental component score

  1 year

• Serious adverse events

  1 year

Other Outcomes (71)

• All-cause mortality

  1 year

• All-cause mortality

  2 year

• All-cause mortality

  After 3 years

Study Arms (2)

Lenient rate control

EXPERIMENTAL

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.

Other: Rate control

Strict rate control

ACTIVE COMPARATOR

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.

Other: Rate control

Interventions

Rate control OTHER

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.

Lenient rate control; Strict rate control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• No informed consent.
• Initial heart rate under 80 bpm at rest (assessed via ECG before randomisation).
• Less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated.
• 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.
• Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion

Sponsors & Collaborators

• Holbaek Sygehus: lead
• Odense University Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Zealand University Hospital: collaborator

Study Sites (4)

Holbæk Hospital

Holbæk, 4300, Denmark

RECRUITING

Hvidovre University Hospital

Hvidovre, 2650, Denmark

NOT YET RECRUITING

Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Zealand University Hospital - Roskilde

Roskilde, 4000, Denmark

NOT YET RECRUITING

Related Publications (2)

• Cold IM, Feinberg JB, Brandes A, Davidsen U, Dixen U, Dominguez H, Gang UJO, Gluud C, Hadad R, Kristensen KE, van Le DT, Nielsen EE, Olsen MH, Pedersen OD, Raymond IE, Sajadieh A, Soja AMB, Jakobsen JC. Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial. Trials. 2023 Apr 1;24(1):250. doi: 10.1186/s13063-023-07247-7.

  PMID: 37005636 DERIVED

• Feinberg JB, Olsen MH, Brandes A, Raymond L, Nielsen WB, Nielsen EE, Stensgaard-Hansen F, Dixen U, Pedersen OD, Gang UJO, Gluud C, Jakobsen JC. Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial. BMJ Open. 2021 Mar 31;11(3):e044744. doi: 10.1136/bmjopen-2020-044744.

  PMID: 33789853 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Joshua Feinberg, MD

  Holbaek University Hospital/University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Feinberg, MD

CONTACT

+45 59484530; jorf@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded. Participants will not be informed of the heart rate target or actual heart rate. Treatment providers managing the heart rate target will not be blinded as the intervention requires information of the heart rate. Other treatment providers will not be informed of the heart rate target.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 9, 2020
• Study Start: March 31, 2021
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Not possible to describe yet but will be made available within a timely manner after publication of results.
• Access Criteria: Sharing will abide by the General Data Protection Regulation and the Danish data protections laws.

Locations

DK (4)