Introduction
Resistant hypertension (RH) poses a significant challenge in clinical management, defined as uncontrolled blood pressure despite the use of at least three antihypertensive agents. With a high risk of cardiovascular events and mortality, there's a pressing need for effective treatment strategies. The compound reserpine and triamterene tablets, a traditional Chinese medicine, have shown promise in this regard.
Study Design
This study employs a randomized crossover clinical trial design to compare the efficacy and safety of two treatment regimens: the compound reserpine and triamterene tablets regimen (A + C + 0) and the standard treatment regimen (A + C + D + spironolactone). Forty patients with RH will be recruited and randomly assigned to two crossover groups, each receiving both treatment regimens over a period of 6 weeks, with a 4-week wash-out period in between.
Objectives
The primary objective is to assess the reduction in average 24-hour systolic blood pressure after 6 weeks of intervention. Secondary outcomes include changes in nighttime and daytime mean ambulatory blood pressure, office blood pressure, and BP control rate, among others.
Significance
This trial is crucial for exploring alternative treatments for RH, especially for patients who cannot tolerate the adverse effects of standard treatments like spironolactone. By simplifying the medication regimen and potentially improving patient compliance, this study could significantly impact the management of resistant hypertension.
Conclusion
The findings from this study could provide valuable insights into the efficacy and safety of compound reserpine and triamterene tablets as an alternative treatment for resistant hypertension, offering hope for better management strategies and improved patient outcomes.
Trial registration: Chinese Clinical Trial Registry ChiCTR2400081878. Registered on March 14, 2024.
