Pokorney Sean D, Nemeth Hayley, Chiswell Karen, Albert Christine, Allyn Nadine, Blanco Rosalia, Butler Javed, Calkins Hugh, Elkind Mitchell S V, Fonarow Gregg C, Fontaine John M, Frankel David S, Fermann Gregory J, Gale Rex, Kalscheur Matthew, Kirchhof Paulus, Koren Andrew, Miller Joseph B, Rashkin Jason, Russo Andrea M, Rutan Christine, Steinberg Benjamin A, Piccini Jonathan P
Duke Clinical Research Institute, Durham, NC; Duke Heart Center, Duke University Medical Center, Durham, NC.
Duke Clinical Research Institute, Durham, NC.
Am Heart J. 2025 Jan;279:66-75. doi: 10.1016/j.ahj.2024.10.001. Epub 2024 Oct 16.
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.
虽然有多项已完成的临床试验探讨了有症状的复发性心房颤动（AF）患者的治疗策略，但尚无针对新发房颤一线节律控制的随机临床试验。近期数据表明，在1年内尽早开始节律控制可改善预后。
在这项嵌套于“遵循房颤指南”注册研究中的开放标签实用性临床试验中，约200个地点将纳入约3000例首次检测出房颤的患者。参与者将被随机（1:1）分为除常规治疗外加用决奈达隆治疗组与单纯常规治疗组。主要终点为随机分组后12个月内首次因任何原因发生心血管（CV）住院或死亡的时间。次要终点将包括一个WIN比率（全因死亡、缺血性卒中或系统性栓塞、心力衰竭住院、急性冠状动脉住院）、CV住院和全因死亡率。将根据房颤对生活质量的影响（AFEQT）从基线到12个月的变化以及梅奥房颤特异性症状量表（MAFSI）的变化来分析患者报告的结局。
CHANGE AFIB研究将确定在首次检测出房颤的患者中，除常规治疗外加用决奈达隆治疗是否优于单纯常规治疗，以预防CV住院或任何原因导致的死亡。该试验还将确定在首次检测出房颤时开始节律控制是否会影响CV事件或改善患者报告的结局。
