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

Completed · Phase 4

Conditions studied: Atrial Fibrillation

In brief

While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected AF. In usual care, these patients are started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) along with stroke prevention therapy. The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved cardiovascular outcomes and quality of life in patients first-detected AF. 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 AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score. The treatment follow-up period will be 12 months. There will be two follow-up visits. Consistent with the pragmatic nature of the trial, the first follow-up will occur between 3 -9 months and the 2nd will occur at 12 months (with a window of +/- 30 days). Approximately 3000 patients will be enrolled and randomly assigned (1:1) to study intervention. The study intervention will be dronedarone 400 mg twice daily in addition to usual care versus usual care alone.

Key facts

Study ID

NCT05130268

Run by

American Heart Association

People needed

339

Starts

2021-10-29

Expected to finish

2024-06-30

Last updated by the study team

2025-01-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >=21 years.
• First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 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.

You may not qualify if…

• Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy.
• Planned cardiothoracic surgery. 4. 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%). 6. Permanent atrial fibrillation. 7. 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 9. 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. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.

Where it is running

• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• HonorHealth Scottsdale Shea Medical Center — Scottsdale, Arizona, United States
• Los Angeles Medical Center (Kaiser Permenente) — Los Angeles, California, United States
• West Los Angeles Medical Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• UC Irvine Medical Center (AKA UCI Health) — Orange, California, United States
• Los Robles Health System - Los Robles Regional Medical Center — Thousand Oaks, California, United States
• UCLA Medical Center - Harbor — Torrance, California, United States
• Colorado Heart & Vascular Group - St. Anthony's Hospital — Lakewood, Colorado, United States
• Colorado Heart & Vascular Group - St. Anthony's North Health Campus — Westminster, Colorado, United States
• Christiana Hospital — Newark, Delaware, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Enmanuel Advanced Research Center, LLC — Miami, Florida, United States
• Life Spring Research Foundation, LLC — Miami, Florida, United States
• Nouvelle Clinical Research LLC — Miami, Florida, United States
• Golden Touch Clinical Research — Miami, Florida, United States
• Excellence Medical And Research, LLC — Miami, Florida, United States
• The Miami Research Group — Miami, Florida, United States
• Ocean Wellness Center, LLC — Miami Gardens, Florida, United States
• Pharma Medical Innovations — Miami Lakes, Florida, United States
• The Angel Medical Research — Miami Lakes, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• Guardian Angel Research Center — Tampa, Florida, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Thomas Hospital — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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