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 - 02/12/24

Doi : 10.1016/j.ahj.2024.10.001

Sean D. Pokorney, MD, MBA ^a,^b, Hayley Nemeth, MS ^a,^b, Karen Chiswell, PhD ^a, Christine Albert, MD ^c, Nadine Allyn, RD, MPH ^d, Rosalia Blanco, MBA ^a, Javed Butler, MD, MPH, MBA ^e,^r, Hugh Calkins, MD ^f, Mitchell S.V. Elkind, MD, MS ^d, Gregg C. Fonarow, MD ^g, John M. Fontaine, MD, MBA ^h, David S. Frankel, MD ⁱ, Gregory J. Fermann, MD ^j, Rex Gale, SHRM-SCP ^k, Matthew Kalscheur, MD ^l, Paulus Kirchhof, MD ^m,^s,^t, Andrew Koren, MD ⁿ, Joseph B. Miller, MD, MS ^o, Jason Rashkin, MD ⁿ, Andrea M. Russo, MD ^p, Christine Rutan ^d, Benjamin A. Steinberg, MD, MHS ^q, Jonathan P. Piccini, MD, MHS ^a,^b,^⁎
^a Duke Clinical Research Institute, Durham, NC
^b Duke Heart Center, Duke University Medical Center, Durham, NC
^c Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA
^d American Heart Association, Dallas, TX
^e Baylor Scott and White Research Institute, Dallas, TX
^f Johns Hopkins Hospital, Baltimore, MD
^g Division of Cardiology, Ronald Reagan-UCLA Medical Center, Los Angeles, CA
^h Drexel University College of Medicine, Philadelphia, PA
ⁱ Cardiovascular Division, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
^j Department of Emergency Medicine, University of Cincinnati College of Medicine, Cincinnati, OH
^k Hilton Head Island Leadership Institute, Hilton Head, SC
^l Department of Medicine, University of Wisconsin, Madison, WI
^m Department of Cardiology, University Heart and Vascular Center UKE Hamburg, Germany
ⁿ Sanofi, Bridgewater, NJ
^o Department of Emergency Medicine, Wayne State University & Henry Ford Hospital, Detroit, MI
^p Division of Cardiovascular Disease, Cooper Medical School of Rowan University, Camden, NJ
^q Department of Medicine, University of Utah, Salt Lake City, UT
^r Department of Medicine, University of Mississippi Medical Center, Jackson, MS
^s German Center of Cardiovascular Research (DZHK), Partner site Hamburg/Kiel/Lübeck, Germany
^t Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK

^⁎Reprint requests: Jonathan P. Piccini, MD, MHS,Professor of Medicine, Duke University Medical Center, Durham, NC 27710.Professor of MedicineDuke University Medical CenterDurhamNC27710

Résumé

Background

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.

Methods

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.

Conclusion

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.

Trial Registration

- NCT05130268

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Plan

Randomization, treatment, and follow-up

Study endpoints

Sample size determination & power

Statistical analysis

Administrative organization

Conclusions

Disclosures

Funding

CRediT authorship contribution statement

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Vol 279

P. 66-75 - janvier 2025 Retour au numéro

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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 - 02/12/24

Résumé

Background

Methods

Conclusion

Trial Registration

Plan

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