Journal article
Design and rationale of a pragmatic randomized clinical trial of early dronedarone versus usual care to change and improve outcomes in persons with first-detected atrial fibrillation - the CHANGE AFIB study
The American heart journal, v 279, pp 66-75
Jan 2025
PMID: 39423993
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
While there are several completed clinical trials that address treatment strategies in patients with symptomatic and recurrent atrial fibrillation (AF), there are no randomized clinical trials that address first-line rhythm control of new-onset AF. Recent data suggest that early initiation of rhythm control within 1 year can improve outcomes.
In this open-label pragmatic clinical trial nested within the Get with The Guidelines Atrial Fibrillation registry, approximately 3,000 patients with first-detected AF will be enrolled at approximately 200 sites. Participants will be randomized (1:1) to treatment with dronedarone in addition to usual care versus usual care alone. The primary endpoint will be time to first cardiovascular (CV) hospitalization or death from any cause through 12 months from randomization. Secondary endpoints will include a WIN ratio (all-cause death, ischemic stroke or systemic embolism, heart failure hospitalization, acute coronary hospitalization), CV hospitalization, and all-cause mortality. Patient reported outcomes will be analyzed based on change in Atrial Fibrillation Effect on Quality of Life (AFEQT) and change in Mayo AF-Specific Symptom Inventory (MAFSI) from baseline to 12 months.
CHANGE AFIB will determine if treatment with dronedarone in addition to usual care is superior to usual care alone for the prevention of CV hospitalization or death from any cause in patients with first-detected AF. The trial will also determine whether initiation of rhythm control at the time of first-detected AF affects CV events or improves patient reported outcomes.
- NCT05130268.
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Details
- Title
- Design and rationale of a pragmatic randomized clinical trial of early dronedarone versus usual care to change and improve outcomes in persons with first-detected atrial fibrillation - the CHANGE AFIB study
- Creators
- Sean D Pokorney - Duke Medical CenterHayley Nemeth - Duke Medical CenterKaren Chiswell - Clinical Research InstituteChristine Albert - Cedars-Sinai Medical CenterNadine Allyn - American Heart AssociationRosalia Blanco - Clinical Research InstituteJaved Butler - Baylor University Medical CenterHugh Calkins - Johns Hopkins HospitalMitchell S V Elkind - American Heart AssociationGregg C Fonarow - Ronald Reagan UCLA Medical CenterJohn M Fontaine - Drexel UniversityDavid S Frankel - University of PennsylvaniaGregory J Fermann - University of Cincinnati Medical CenterRex Gale - Hilti (Liechtenstein)Matthew Kalscheur - University of Wisconsin–MadisonPaulus Kirchhof - Universität HamburgAndrew Koren - Sanofi (United States)Joseph B Miller - Wayne State UniversityJason Rashkin - Sanofi (United States)Andrea M Russo - Cooper Medical School of Rowan UniversityChristine Rutan - American Heart AssociationBenjamin A Steinberg - University of UtahJonathan P Piccini (Corresponding Author) - Duke Medical Center
- Publication Details
- The American heart journal, v 279, pp 66-75
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Medicine
- Web of Science ID
- WOS:001359220800001
- Scopus ID
- 2-s2.0-85208969720
- Other Identifier
- 991022197422104721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems