Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation (CHANGE-AFIB)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Arrhythmias, Cardiac, Atrial Fibrillation, Anti-Arrhythmic Agents, Heterocyclic Compounds, Dronedarone, Multaq
Eligibility Criteria
Inclusion Criteria:
- Age >=21 years
- First-detected atrial fibrillation (defined as atrial fibrillation 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:
- Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy.
- Prior hospitalization for AF (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.
Sites / Locations
- Thomas HospitalRecruiting
- Mercy Gilbert Medical CenterRecruiting
- HonorHealth Scottsdale Shea Medical CenterRecruiting
- Los Angeles Medical Center (Kaiser Permenente)Recruiting
- West Los Angeles Medical CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- UC Irvine Medical Center (AKA UCI Health)Recruiting
- Los Robles Health System - Los Robles Regional Medical CenterRecruiting
- UCLA Medical Center - HarborRecruiting
- Colorado Heart & Vascular Group - St. Anthony's HospitalRecruiting
- Colorado Heart & Vascular Group - St. Anthony's North Health CampusRecruiting
- Christiana HospitalRecruiting
- First Coast Cardiovascular InstituteRecruiting
- Ocean Wellness Center, LLCRecruiting
- Pharma Medical InnovationsRecruiting
- The Angel Medical ResearchRecruiting
- Enmanuel Advanced Research Center, LLCRecruiting
- Life Spring Research Foundation, LLCRecruiting
- Nouvelle Clinical Research LLCRecruiting
- Golden Touch Clinical ResearchRecruiting
- Excellence Medical And Research, LLCRecruiting
- The Miami Research GroupRecruiting
- Northside HospitalRecruiting
- Guardian Angel Research CenterRecruiting
- Northeast Georgia Medical CenterRecruiting
- Georgia Arrhythmia Consultants and Research InstituteRecruiting
- Wellstar Kennestone HospitalRecruiting
- Mt Sinai Hospital Medical CenterRecruiting
- Rush University Medical CenterRecruiting
- University of Illinois HospitalRecruiting
- Riverside Medical CenterRecruiting
- Loyola University Medical CenterRecruiting
- Captain James A Lovell Federal Health Care CenterRecruiting
- Proctor Community HospitalRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Trinity Rock IslandRecruiting
- St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. FrancisRecruiting
- St. John's Hospital of the Hospital Sisters of the Third Order of St. FrancisRecruiting
- Carle Foundation HospitalRecruiting
- Parkview Hospital, Inc.Recruiting
- Ascension St Vincent Hospital - IndianapolisRecruiting
- Kansas City Heart and Vascular Specialists at Providence Medical CenterRecruiting
- Overland Park Regional Medical CenterRecruiting
- Baptist Health LexingtonRecruiting
- Saint Joseph HospitalRecruiting
- Heart Clinic of HammondRecruiting
- Tulane Medical CenterRecruiting
- Luminis Health Anne Arundel Medical CenterRecruiting
- Saint Agnes HospitalRecruiting
- Adventist Healthcare Shady Grove Medical CenterRecruiting
- Brigham and Womens HospitalRecruiting
- McLaren Bay RegionRecruiting
- DMC Harper University Hospital (AKA Wayne State University Hospital)Recruiting
- Sparrow HospitalRecruiting
- McLaren MacombRecruiting
- Trinity Health Ann Arbor Hospital - Michigan HeartRecruiting
- Minneapolis VA Health Care SystemRecruiting
- University Hospital - University of MissouriRecruiting
- Barnes-Jewish Hospital (AKA Washington Univ)Recruiting
- SSM Health Saint Louis University HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- CHI Health Creighton University Medical Center - Bergan MercyRecruiting
- Cooper University HospitalRecruiting
- The Valley HospitalRecruiting
- Albany Medical CenterRecruiting
- NYC Health and Hospitals - LincolnRecruiting
- NYC Health and Hospitals - JacobiRecruiting
- NYC Health and Hospitals - North Central BronxRecruiting
- NewYork-Presbyterian/Columbia University Irving Medical CenterRecruiting
- Memorial Sloan KetteringRecruiting
- DiGiovanna Institute for Medical Education & ResearchRecruiting
- Duke University HospitalRecruiting
- Durham VA Health Care SystemRecruiting
- WakeMed Raleigh CampusRecruiting
- New Hanover Regional Medical CenterRecruiting
- Trinity HospitalRecruiting
- The MetroHealth SystemRecruiting
- Kettering Health DaytonRecruiting
- Miami Valley HospitalRecruiting
- Kettering Medical CenterRecruiting
- McLaren - St Lukes HospitalRecruiting
- Wooster Community Hospital Health SystemRecruiting
- Oklahoma City VA Health Care SystemRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Penn State Health Holy Spirit Medical CenterRecruiting
- Penn State Health Milton S Hershey Medical CenterRecruiting
- Penn State Health St Joseph Medical Center - Main CampusRecruiting
- Ascension Saint Thomas MidtownRecruiting
- Ascension Seton Medical Center AustinRecruiting
- Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth)Recruiting
- Memorial Hermann - Texas Medical CenterRecruiting
- Texas Institute of CardiologyRecruiting
- Synapse Clinical ResearchRecruiting
- University Hospital at University of Texas San AntonioRecruiting
- University of Utah HospitalRecruiting
- Chippenham and Johnston Willis Medical CenterRecruiting
- Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center)Recruiting
- JW Ruby Memorial HospitalRecruiting
- Mayo Clinic Hospital - Franciscan Healthcare La CrosseRecruiting
- UW Health at the American Center (AKA UW Health East Madison Hospital)Recruiting
- University Hospital - University of Wisconsin-MadisonRecruiting
- Marshfield Medical CenterRecruiting
- Marshfield Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Dronedarone
Usual care
In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the United States Prescribing Information (USPI) when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.
In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.