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Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).
Title {1} | The antihypertensive efficacy of a quadruple single-pill combination in patients with resistant hypertension: Study protocol for a randomized, open-label, crossover trial |
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Trial registration {2a and 2b}. | Chinese Clinical Trials Registry; Code: ChiCTR2400081878; Registered on March 14, 2024. |
Protocol version {3} | This is the second version of the protocol, finalized on December 6, 2023. |
Funding {4} | This trial is supported by the Department of Cardiology, West China Hospital without involvement in study design, collection, analysis and manuscript writing. |
Author details {5a} | Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Yuanyuan Yao Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Xin Zhang Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Runyu Ye Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Shanshan Jia Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Xiangyu Yang Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China. Xiaoping Chen |
Name and contact information for the trial sponsor {5b} | West China Hospital Postal Code: 610041 Tell: 028–85422114. |
Role of sponsor {5c} | Financial support and supervision. |
Introduction
Background and rationale {6a}
Resistant hypertension (RH) is treated as a specific phenotype of hypertension defined as BP that remains above target despite the concurrent use of three different antihypertensive agents including long-acting calcium-channel blockers (C:CCB), renin-angiotensin system blockers (A:ACEI/ARB), and diuretics (D) [1]. A recent meta-analysis reported that almost 10.3% of hypertensive patients taking antihypertensive drugs globally suffer from RH [2]. Moreover, RH is likely to be more prevalent in patients with obesity, diabetes, or chronic kidney disease (CKD) [3, 4]. In addition, it is known to be associated with a greater risk of end-organ damage and cardiovascular events [5, 6]. Compared with those with non-resistant hypertension, patients with RH have been demonstrated to have a 32% increased risk of end-stage renal disease (ESRD), a 24% increased risk of ischemic heart event (IHE), a 46% increased risk of congestive heart failure (CHF), and a 6% increased risk of all-cause mortality [5]. The high prevalence and poor prognosis of RH impose a considerable social...