Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.
Trials. 2021 Jul 18;22(1):462. doi: 10.1186/s13063-021-05411-5.
BACKGROUND: With the expanded utilization of transcatheter aortic valve implantation (TAVI) to younger and lower surgical risk patients with severe aortic stenosis (AS), optimal medical therapy after TAVI procedure has become the main concern. Renin-angiotensin system inhibitors (RASi) are widely utilized in the area of cardiovascular disease including heart failure and myocardial infarction and revealed the ability to reverse left ventricular (LV) remodeling. Interests have, thus, been drawn in investigating whether the prescription of RASi after the TAVI procedure can prevent or reverse cardiac remodeling and improve long-term clinical outcomes. No recommendation regarding the prescription of RASi after TAVI is proposed yet due to the lack of evidence from randomized controlled trials, especially in the Chinese population. We, therefore, designed this randomized controlled trial to explore the effect of adding fosinopril to standard care in patients who underwent a successful TAVI procedure on the LV remodeling. METHODS: A total of 200 post-TAVI patients from seven academic hospitals across China will be recruited and randomized with a ratio of 1:1 to receive standard care or standard care plus fosinopril. Follow-up visits will take place at 30 days, 3 months, 6 months, 12 months, and 24 months from randomization to assess the clinical symptoms, any adverse events, cardiac function, and quality of life. Cardiac magnetic resonance will be performed at baseline and repeated at the 24-month follow-up visit to assess LV remodeling. DISCUSSION: This study will provide evidence regarding medical therapy for AS patients who underwent TAVI and filling the gap in the Chinese population. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100042266 . Registered on 17 January 2021.
背景:随着经导管主动脉瓣植入术(TAVI)在患有严重主动脉瓣狭窄(AS)的年轻和低手术风险患者中的广泛应用,TAVI 术后的最佳药物治疗已成为主要关注点。肾素-血管紧张素系统抑制剂(RASi)广泛应用于心力衰竭和心肌梗死等心血管疾病领域,并且已显示出逆转左心室(LV)重构的能力。因此,人们对 TAVI 术后开具 RASi 处方是否可以预防或逆转心脏重构并改善长期临床结局产生了兴趣。由于缺乏随机对照试验的证据,特别是在中国人中,目前尚未提出关于 TAVI 术后开具 RASi 处方的建议。因此,我们设计了这项随机对照试验,以探讨在成功进行 TAVI 手术后的患者中,加用福辛普利对标准治疗的 LV 重构的影响。
方法:将从中国 7 家学术医院招募 200 名 TAVI 术后患者,按照 1:1 的比例随机分为标准治疗组或标准治疗加福辛普利组。随访将在随机分组后 30 天、3 个月、6 个月、12 个月和 24 个月进行,以评估临床症状、任何不良事件、心功能和生活质量。基线时和 24 个月随访时将进行心脏磁共振检查,以评估 LV 重构。
讨论:这项研究将为 TAVI 术后 AS 患者的药物治疗提供证据,并填补中国人群中的空白。
试验注册:中国临床试验注册中心 ChiCTR2100042266 。注册于 2021 年 1 月 17 日。
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