Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study
Introduction Hypertension constitutes the primary health burden of cardiovascular diseases, and the global control of blood pressure (BP) remains insufficient. Single pill combinations (SPCs) are employed as a means to streamline the management of poor BP control due to non-adherence and treatment i...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e092109.full |
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| author | Kai Liu Yu Yan Xin Zhang Yanan Li Yuanyuan Yao Lu Liu Runyu Ye Si Wang Xiangyu Yang Xiaoping Chen Shanshan Jia Qingtao Meng Xianghao Zuo |
| author_facet | Kai Liu Yu Yan Xin Zhang Yanan Li Yuanyuan Yao Lu Liu Runyu Ye Si Wang Xiangyu Yang Xiaoping Chen Shanshan Jia Qingtao Meng Xianghao Zuo |
| author_sort | Kai Liu |
| collection | DOAJ |
| description | Introduction Hypertension constitutes the primary health burden of cardiovascular diseases, and the global control of blood pressure (BP) remains insufficient. Single pill combinations (SPCs) are employed as a means to streamline the management of poor BP control due to non-adherence and treatment inertia. The compound reserpine and triamterene tablets constitute a quadruple SPC, comprising reserpine 0.1 mg, dihydralazine 12.5 mg, hydrochlorothiazide 12.5 mg and triamterene 12.5 mg. It is widely employed in primary medical institutions and has favourable efficacy, tolerability and cost-effectiveness.Methods and analysis The COSPQ-BP trial is a 12-week prospective randomised controlled trial to enrol 1332 patients with primary mild-to-moderate hypertension. Participants who meet the inclusion criteria will be randomly assigned to a 1:1 ratio to an intervention group (compound reserpine and triamterene tablets) or a control group (valsartan/hydrochlorothiazide). The primary outcome will be mean changes from baseline in 24-hour ambulatory systolic BP after intervention for 12 weeks. The secondary outcomes have been predetermined and will primarily encompass the following: (1) changes in other BP measures, as well as changes in blood lipids, blood glucose and uric acid at 12 weeks and (2) evaluation of the impact of starting antihypertensive therapy with compound reserpine and triamterene tablets or valsartan/hydrochlorothiazide on the depressive and anxiety statess of patients.Ethics and dissemination The study protocol (version number: V5.0, version date: 17 January 2023) has been approved by the ethics committee (Biomedical Ethics Committee of West China Hospital of Sichuan University, approval number: Review (51) in 2023). Written informed consent will be obtained from each participant by researchers. The findings of this study will be disseminated through conference presentations and peer-reviewed publications.Trial registration This study was registered at the Chinese Clinical Trials Registry (ChiCTR2300067920). The COSPQ-BP trial is currently enrolling. The study period will be from 1 January 2024 to 31 December 2025. |
| format | Article |
| id | doaj-art-7b8e0265af3f43639df6a061af6bda84 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-7b8e0265af3f43639df6a061af6bda842025-02-08T07:15:12ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-092109Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled studyKai Liu0Yu Yan1Xin Zhang2Yanan Li3Yuanyuan Yao4Lu Liu5Runyu Ye6Si Wang7Xiangyu Yang8Xiaoping Chen9Shanshan Jia10Qingtao Meng11Xianghao Zuo12Department of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaDepartment of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, ChinaIntroduction Hypertension constitutes the primary health burden of cardiovascular diseases, and the global control of blood pressure (BP) remains insufficient. Single pill combinations (SPCs) are employed as a means to streamline the management of poor BP control due to non-adherence and treatment inertia. The compound reserpine and triamterene tablets constitute a quadruple SPC, comprising reserpine 0.1 mg, dihydralazine 12.5 mg, hydrochlorothiazide 12.5 mg and triamterene 12.5 mg. It is widely employed in primary medical institutions and has favourable efficacy, tolerability and cost-effectiveness.Methods and analysis The COSPQ-BP trial is a 12-week prospective randomised controlled trial to enrol 1332 patients with primary mild-to-moderate hypertension. Participants who meet the inclusion criteria will be randomly assigned to a 1:1 ratio to an intervention group (compound reserpine and triamterene tablets) or a control group (valsartan/hydrochlorothiazide). The primary outcome will be mean changes from baseline in 24-hour ambulatory systolic BP after intervention for 12 weeks. The secondary outcomes have been predetermined and will primarily encompass the following: (1) changes in other BP measures, as well as changes in blood lipids, blood glucose and uric acid at 12 weeks and (2) evaluation of the impact of starting antihypertensive therapy with compound reserpine and triamterene tablets or valsartan/hydrochlorothiazide on the depressive and anxiety statess of patients.Ethics and dissemination The study protocol (version number: V5.0, version date: 17 January 2023) has been approved by the ethics committee (Biomedical Ethics Committee of West China Hospital of Sichuan University, approval number: Review (51) in 2023). Written informed consent will be obtained from each participant by researchers. The findings of this study will be disseminated through conference presentations and peer-reviewed publications.Trial registration This study was registered at the Chinese Clinical Trials Registry (ChiCTR2300067920). The COSPQ-BP trial is currently enrolling. The study period will be from 1 January 2024 to 31 December 2025.https://bmjopen.bmj.com/content/15/2/e092109.full |
| spellingShingle | Kai Liu Yu Yan Xin Zhang Yanan Li Yuanyuan Yao Lu Liu Runyu Ye Si Wang Xiangyu Yang Xiaoping Chen Shanshan Jia Qingtao Meng Xianghao Zuo Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study BMJ Open |
| title | Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study |
| title_full | Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study |
| title_fullStr | Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study |
| title_full_unstemmed | Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study |
| title_short | Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised controlled study |
| title_sort | efficacy of chinese traditional quadruple single pill combination versus valsartan hydrochlorothiazide for the treatment of hypertension cospq bp study protocol for randomised controlled study |
| url | https://bmjopen.bmj.com/content/15/2/e092109.full |
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