School of Medicine, Southeast University, Nanjing, China.
Department of Cardiology, Jinling Hospitial, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Trials. 2023 May 9;24(1):318. doi: 10.1186/s13063-023-07332-x.
Heart failure with reduced ejection fraction (HFrEF) is associated with sleep dyspnea (SDB), which plays an adverse role in the pathophysiology of the condition. SDB management in HFrEF, however, remains controversial. HFrEF's medical management has recently made significant progress with the discovery of new therapeutic avenues, namely sodia-glucose cotransporter-2 (SGLT-2) inhibitors, and better treatment of co-morbidities. Dapagliflozin, one of the SGLT-2 inhibitors, is a good candidate for correcting SDB of HFrEF patients because their known mechanisms of action are likely to counteract the pathophysiology of SDB in HFrEF.
METHODS/DESIGN: The trial is a 3-month, multicentric, prospective, randomized controlled clinical study. Patients (i.e., adults with left ventricular ejection fraction ≤ 40%, Apnoea-Hypopnoea Index ≥ 15) will be randomized to receive optimized heart failure therapy plus a standard dose of dapagliflozin, while the control group will receive only optimized heart failure therapy. Patients will be evaluated before and after 3 months (nocturnal ventilatory polygraphy, echocardiography, laboratory testing, and quality-of-life and SDB questionnaires). The primary outcome is the change in the Apnoea-Hypopnoea Index, before and after 3 months of treatment.
www.chictr.org.cn , ChiCTR2100049834. Registered 10 August 2021.
射血分数降低的心力衰竭（HFrEF）与睡眠呼吸暂停（SDB）相关，后者在该病的病理生理学中发挥不良作用。然而，HFrEF 中的 SDB 管理仍存在争议。随着新治疗途径（即钠-葡萄糖共转运蛋白-2（SGLT-2）抑制剂）的发现以及合并症治疗的改善，HFrEF 的医学管理最近取得了重大进展。SGLT-2 抑制剂中的达格列净是纠正 HFrEF 患者 SDB 的候选药物，因为其已知的作用机制可能对抗 HFrEF 中 SDB 的病理生理学。
方法/设计：该试验是一项为期 3 个月、多中心、前瞻性、随机对照临床研究。患者（即左心室射血分数≤40%、呼吸暂停-低通气指数≥15 的成年人）将被随机分为接受优化的心力衰竭治疗加标准剂量的达格列净组，而对照组仅接受优化的心力衰竭治疗。患者将在治疗前和治疗后 3 个月进行评估（夜间通气多导睡眠图、超声心动图、实验室检查以及生活质量和 SDB 问卷）。主要结局是治疗 3 个月后呼吸暂停-低通气指数的变化。
www.chictr.org.cn，ChiCTR2100049834。注册于 2021 年 8 月 10 日。
