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

  • STATUS
    Recruiting
  • End date
    Mar 2, 2026
  • participants needed
    350
  • sponsor
    Holbaek Sygehus
Updated on 1 April 2021

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.

Details
Condition Arrhythmia, Atrial Fibrillation, Chronic Atrial Fibrillation, Atrial Fibrillation Chronic, Atrial Fibrillation (Pediatric), Dysrhythmia, Atrial Fibrillation, Persistent, Atrial Fibrillation, Persistent, Atrial Fibrillation, Persistent, Atrial Fibrillation, Persistent
Treatment Rate Control
Clinical Study IdentifierNCT04542785
SponsorHolbaek Sygehus
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Informed consent
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)
Adult (18 years or older)

Exclusion Criteria

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
Participants dependent on a high ventricular rate to maintain a sufficient cardiac output. This will be based on an individual assessment of the possible participant
Such participants could be participants with heart failure, participants with
a haemodynamically significant valve dysfunction or severely dehydrated
participants
Other factors such as echocardiographic assessments, stability of the disease
and similar will be factored in when judging if a participant is dependent on
a high ventricular rate. Such a decision will be made before randomisation by
the treatment provider
\. Participants who cannot tolerate a lenient rate control strategy (e.g. in
case of tachycardia induced cardiomyopathy). This will be based on an
individual assessment of the possible participant. Such a decision will be
made before randomisation by the treatment provider
\. Participants who are haemodynamically unstable and therefore require
immediate electrical cardioversion
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note