Yao Yuanyuan, Zhang Xin, Ye Runyu, Jia Shanshan, Yang Xiangyu, Chen Xiaoping
Cardiology Department, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, People's Republic of China.
Trials. 2025 Jan 20;26(1):22. doi: 10.1186/s13063-025-08719-8.
Resistant hypertension (RH) is defined as uncontrolled blood pressure (BP) despite treatment with at least three or more antihypertensive agents. Compelling evidence has shown that such a population has a greater risk of cardiovascular events as well as mortality. Although mineralocorticoid receptor antagonists (MRAs) have been shown to be an effective fourth-line treatment for RH, a significant proportion of RH patients do not achieve their blood pressure target. Compound reserpine and triamterene tablets, a traditional Chinese quadruple single-pill combination, have been proven to have good antihypertensive effects as well as safety, and are promising effective antihypertensive drugs for treating RH.
A randomized crossover clinical trial will be conducted to compare the efficacy and safety of compound reserpine and triamterene tablets treatment regimen (two tablets of olmesartan/amlodipine (OA) + one tablet of compound reserpine and triamterene tablets) with those of a standard treatment regimen (two tablets of OA + indapamide 2.5 mg + spironolactone 20 mg) in patients with RH. Forty patients will be recruited and randomly assigned in a 1:1 ratio to 2 crossover groups. The two groups will receive different combination therapies for 6 weeks and will then switch to the other combination therapy for 6 weeks, with a 4-week wash-out. The primary outcome will be the reduction in average 24-h systolic blood pressure after 6 weeks of intervention between the two groups.
This study aimed to evaluate whether the compound reserpine and triamterene tablets treatment regimen (A + C + 0) results in a greater reduction in blood pressure in RH patients than the standard treatment regimen (A + C + D + spironolactone).
Chinese Clinical Trial Registry ChiCTR2400081878. Registered on March 14, 2024 ( http://www.chictr.org.cn ).
顽固性高血压（RH）的定义为尽管使用了至少三种或更多种抗高血压药物治疗，但血压仍未得到控制。有力证据表明，这类人群发生心血管事件以及死亡的风险更高。尽管盐皮质激素受体拮抗剂（MRAs）已被证明是治疗RH的一种有效的四线治疗药物，但仍有相当一部分RH患者未达到其血压目标。复方利血平氨苯蝶啶片，一种传统的中药四联单片复方制剂，已被证明具有良好的降压效果和安全性，是治疗RH的有前景的有效降压药物。
将进行一项随机交叉临床试验，比较复方利血平氨苯蝶啶片治疗方案（两片奥美沙坦/氨氯地平（OA）+一片复方利血平氨苯蝶啶片）与标准治疗方案（两片OA+2.5mg吲达帕胺+20mg螺内酯）在RH患者中的疗效和安全性。将招募40名患者，并按1:1的比例随机分配到2个交叉组。两组将接受不同的联合治疗6周，然后切换到另一种联合治疗6周，中间有4周的洗脱期。主要结局将是两组干预6周后24小时平均收缩压的降低情况。
本研究旨在评估复方利血平氨苯蝶啶片治疗方案（A+C+0）是否比标准治疗方案（A+C+D+螺内酯）能使RH患者的血压降低更多。
中国临床试验注册中心ChiCTR2400081878。于2024年3月14日注册（http://www.chictr.org.cn）。
