Chronic Remote Ischemic Conditioning on Mild Hypertension in the Absence of Antihypertensive Medication: A Multicenter, Randomized, Double-Blind, Proof-of-Concept Clinical Trial
Chronic Remote Ischemic Conditioning on Mild Hypertension in the Absence of Antihypertensive Medication: A Multicenter, Randomized, Double-Blind, Proof-of-Concept Clinical Trial
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DOI：
10.1161/hypertensionaha.122.20934
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发表时间：
2023-06-01
期刊：
影响因子：
8.3
通讯作者：
Ji，Xunming
中科院分区：
文献类型：
--
作者：
Guo，Wenting;Zhao，Wenbo;Ji，Xunming
背景探索性研究表明，远程缺血预处理（RIC）具有降低血压（BP）的潜力。我们调查是否慢性RIC降低血压高血压。MethodsThis是一个多中心，随机，双盲，平行对照试验。招募了诊室血压为130/80至160/100 mm Hg且24小时平均血压≥125/75 mm Hg且未接受抗高血压药物治疗的患者。在1周的依从性筛选阶段后，他们以1：1的比例随机分配接受RIC或假RIC，每天两次，持续4周。主要疗效结局为24小时平均收缩压从基线至第4周的变化。安全事件进行了评估，在研究periods.Results95名参与者被随机分配到RIC（n=49）和假RIC（n=46）组。在意向治疗分析中，RIC组24小时平均收缩压的降低幅度大于假RIC组（−4.6±9.5 vs −0.9±6.8 mm Hg;基线校正的组间平均差异：−3.6 mm Hg [95% CI，−6.9至−0.3 mm Hg];校正后P =0.035）。符合方案分析显示，RIC组的24小时平均收缩压降低了−5.9±8.6 mm Hg，假RIC组降低了−0.7±6.7 mm Hg（基线校正的组间平均差异：−5.2 mm Hg [95% CI，−8.5至−1.9 mm Hg];校正后P =0.002）。两组均无重大不良事件报告。结论RIC在轻度高血压患者中是安全的，在没有降压药物的情况下可能会降低血压。然而，RIC对这些患者临床结局的影响需要进一步研究。https://www.clinicaltrials.gov
BackgroundExploratory studies have shown that remote ischemic conditioning (RIC) has the potential to lower blood pressure (BP). We investigated whether chronic RIC reduces BP for hypertension.MethodsThis is a multicenter, randomized, double-blind, parallel-controlled trial. Patients with an office BP of 130/80 to 160/100 mm Hg and a 24-hour average BP ≥125/75 mm Hg not on antihypertensive medications were recruited. After a 1-week compliance screening phase, they were randomly assigned in a 1:1 ratio to receive RIC or sham RIC twice daily for 4 weeks. The primary efficacy outcome was the change in 24-hour average systolic BP from baseline to 4 weeks. Safety events were assessed over the study period.ResultsNinety-five participants were randomly allocated to the RIC (n=49) and sham RIC (n=46) groups. In the intention-to-treat analysis, the reduction in 24-hour average systolic BP was greater in the RIC group than the sham RIC group (−4.6±9.5 versus −0.9±6.8 mm Hg; baseline-adjusted between-group mean difference: −3.6 mm Hg [95% CI, −6.9 to −0.3 mm Hg]; adjustedP=0.035). The per-protocol analysis showed that 24-hour average systolic BP reduced −5.9±8.6 mm Hg in the RIC group and −0.7±6.7 mm Hg in the sham RIC group (baseline-adjusted between-group mean difference: −5.2 mm Hg [95% CI, −8.5 to −1.9 mm Hg]; adjustedP=0.002). No major adverse events were reported in both groups.ConclusionsRIC is safe in patients with mild hypertension and may lower BP in the absence of antihypertensive medications. However, the effects of RIC on clinical outcomes in these patients require further investigation.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT04915313.