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

Launched by HOLBAEK SYGEHUS · Sep 2, 2020

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ClinConnect Summary

This clinical trial, called the Danish Atrial Fibrillation Randomised Clinical Trial, is investigating two different ways to manage atrial fibrillation, a common heart condition where the heart beats irregularly. The trial will compare a lenient approach, where doctors allow the heart rate to be a bit higher, against a strict approach, where they aim for a lower heart rate. This study is important because it will help us understand which method is better for patients with persistent or permanent atrial fibrillation, potentially leading to improved care.

To be eligible for the trial, participants must be adults aged 18 or older and have a confirmed diagnosis of atrial fibrillation that has lasted more than a week. They also need to agree that controlling the heart rate will be their main treatment. Participants will be randomly assigned to one of the two management strategies and will be monitored closely throughout the study. This trial is currently recruiting participants, and it’s a great opportunity for those who want to contribute to advancing our understanding of atrial fibrillation treatment.

Gender

ALL

Eligibility criteria

• 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