Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation

Overview

About this study

The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected  atrial fibrillation (AF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:  

  • Age ≥ 21 years.
  • First-detected atrial fibrillation (defined as  diagnosed in the previous 120 days).
  • Acute care encounter for evaluation or treatment of atrial fibrillation, within 120 days.
  • Electrocardiographic documentation of atrial fibrillation. 
  • Estimated life expectancy of at least 1 year.
  • Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:  

  • Age < 21 years old.
  • First-Detected AFib > 120 days ago.
  • No Acute Care Encounter for the diagnosis of first-detected AFib.
  • Estimated life expectancy < 1 year.
  • Patients with prior or planned treatment with rhythm control, either catheter ablation or antiarrhythmic drug therapy.
  • Prior hospitalization for atrial fibrillation (other than the qualifying event).
  • Planned cardiothoracic surgery.
  • New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks.
  • Patients with reduced ejection fraction (LVEF ≤ 40%).
  • Permanent atrial fibrillation.
  • Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men.
  • Bradycardia with a resting heart rate < 50 bpm.
  • PR interval > 280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device.
  • Corrected QT interval ≥ 500 msec.
  • Pregnancy or breast feeding.
  • Severe hepatic impairment in the opinion of the investigator.
  • Other: (specify reason).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/18/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

La Crosse, Wis.

Mayo Clinic principal investigator

Xiaoke Liu, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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