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

NCT04542785 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Holbaek Sygehus

    lead OTHER

Principal Investigators

  • Joshua Feinberg, MD · Holbaek University Hospital/University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2026-03-02
Completion
2026-03-02

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542785 on ClinicalTrials.gov