Why the study?
Although mineralocorticoid receptor antagonists are effective fourth-line agents for resistant hypertension, many patients still do not achieve blood pressure targets.
Does a compound reserpine and triamterene tablet regimen reduce blood pressure more than a standard regimen (indapamide + spironolactone) in patients with resistant hypertension?
Does a compound reserpine and triamterene tablet regimen reduce blood pressure more than a standard regimen (indapamide + spironolactone) in patients with resistant hypertension?
This study protocol outlines a randomized crossover trial to evaluate the antihypertensive efficacy of a compound reserpine and triamterene tablet regimen compared to standard therapy in patients with resistant hypertension.
Answers are grounded in this paper and cite their sources.
RCT protocol tests reserpine-triamterene versus standard therapy in resistant hypertension; leaves open comparative efficacy.
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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). TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400081878. Registered on March 14, 2024 ( http://www.chictr.org.cn ).
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Yao et al. (2025) studied this question.
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