Cardiology Department, West China Hospital, Sichuan University, Chengdu, Sichuan Province, 610041, People's Republic of China.
Trials. 2023 Nov 28;24(1):770. doi: 10.1186/s13063-023-07726-x.
Hypertension increases the risk of cardiovascular disease. Uncontrolled nocturnal blood pressure is prevalent in patients taking antihypertensive medication, with an incidence rate of 30-60%. Although chronotherapy with antihypertensive agents may provide a new direction for effective control of nocturnal blood pressure, the clinical evidence base remains controversial. This research is presently underway to compare the effects of morning and bedtime administration of antihypertensive medication on nocturnal reduction and circadian rhythm of blood pressure in patients with hypertension.
This study is being performed as a randomized, multicenter, open-label, parallel-group, clinical trial in which 720 participants are to undergo 24-h ambulatory blood pressure measurement (ABPM) and office blood pressure measurement (OBPM) at baseline before being randomly assigned to a morning (6-10 am) or a bedtime (6-10 pm) administration group. Each participant receives one 20/5-mg tablet of olmesartan/amlodipine (OA) daily for 4 weeks and is then followed up at 4-week intervals for a total of 12 weeks. During follow-up, the OA dosage is adjusted according to the ABPM and OBPM results. Patients with uncontrolled hypertension at the first follow-up visit will receive an increase in OA dosage to 1.5 tablets/day. For patients with blood pressure that is still uncontrolled after a further 4 weeks, the dosage of OA can be increased to 2 tablets/day. The primary objective is the reduction in mean nocturnal systolic blood pressure between baseline and week 12. The secondary objectives are the reduction in ambulatory blood pressure at weeks 4 and 12 and the blood pressure control rate at weeks 4, 8, and 12.
Antihypertensive chronotherapy remains controversial. A superiority test hypothesis design has been adopted for this trial, in which all participants will be taking the same antihypertensive medication. We anticipate that our findings will determine if nocturnal blood pressure control in Chinese patients with essential hypertension varies according to whether antihypertensive medication is taken in the morning or at bedtime. This study may provide scientific evidence for the application of chronotherapy in clinical practice.
ChiCTR2200059719. Registered on 10 May 2022 ( http://www.chictr.org.cn/edit.aspx?pid=169782&htm=4 ) {2a,2b}.
高血压会增加心血管疾病的风险。服用抗高血压药物的患者中普遍存在未得到控制的夜间血压，其发生率为 30-60%。尽管抗高血压药物的时间治疗可能为有效控制夜间血压提供新的方向，但临床证据仍存在争议。目前正在进行这项研究，以比较早晨和睡前服用抗高血压药物对高血压患者夜间血压降低和昼夜节律的影响。
这是一项在 720 名参与者中进行的随机、多中心、开放标签、平行组临床试验，这些参与者在基线时进行 24 小时动态血压测量（ABPM）和诊室血压测量（OBPM），然后随机分为早晨（6-10 点）或睡前（6-10 点）给药组。每个参与者每天服用一次 20/5 毫克奥美沙坦/氨氯地平（OA）片剂，持续 4 周，然后每隔 4 周随访一次，共 12 周。在随访期间，根据 ABPM 和 OBPM 结果调整 OA 剂量。在第一次随访时血压控制不佳的患者将增加 OA 剂量至 1.5 片/天。对于进一步 4 周后血压仍未得到控制的患者，可以将 OA 剂量增加至 2 片/天。主要终点是从基线到第 12 周时平均夜间收缩压的降低。次要终点是第 4 周和第 12 周时 ABPM 的降低以及第 4、8 和 12 周时的血压控制率。
抗高血压时间治疗仍然存在争议。本试验采用了优势测试假设设计，所有参与者都将服用相同的抗高血压药物。我们预计我们的研究结果将确定中国原发性高血压患者的夜间血压控制是否因抗高血压药物是在早晨还是在睡前服用而有所不同。这项研究可能为时间治疗在临床实践中的应用提供科学依据。
ChiCTR2200059719。于 2022 年 5 月 10 日注册（http://www.chictr.org.cn/edit.aspx?pid=169782&htm=4）{2a,2b}。
