Safety, Acceptability and Efficacy of Noninvasive Transcutaneous-Autonomic Neuromodulation in Uncontrolled Hypertension.

IF 9.8 1区医学 Q1 PERIPHERAL VASCULAR DISEASE

Hypertension Pub Date : 2026-09-28 DOI:10.1161/HYPERTENSIONAHA.126.27847

Ajay Gupta, David Collier, James Steckelmacher, Jane Field, George Collett, Olivier Zongo, Mital Patel, Manish Saxena, Annastazia Learoyd, Amrita Ahluwalia, Peter Sever

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引用次数: 0

Abstract

Background: Despite antihypertensive medications, ≈40% of patients with hypertension fail to achieve recommended blood pressure (BP) targets. Alternative device-based strategies are often expensive or invasive. We evaluated the safety, acceptability, and potential efficacy of a noninvasive transcutaneous autonomic neuromodulation (tAN) device.

Methods: SCRATCH-HTN (Sham Controlled Randomized Trial Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation using Transcutaneous Vagal Sensory Stimulation in Uncontrolled Hypertensive Patients) was a double-blind, sham-controlled, phase 2a trial enrolling patients with uncontrolled hypertension (mean daytime systolic BP [SBP] ≥135 mm Hg and diastolic BP ≥85 mm Hg) on 1 or more medications. Participants self-administered active tAN or sham treatment for 30 minutes daily for 14 days, then 10 weekly sessions. Primary end points were safety and acceptability. The primary efficacy end point was change in daytime ambulatory SBP from baseline to 3 months. Secondary end points included BP, heart rate, and quality of life at 1 and 3 months.

Results: Sixty-three patients (mean age 47.2 years, 71.4% male, mean daytime BP 150/95 mm Hg) were randomized 2:1 to tAN or sham. tAN did not differ significantly from sham in daytime ambulatory SBP at 3 months (between-group difference, 2.35 mm Hg [95% CI, -4.37 to 9.07]; P=0.49) or 1 month (-1.01 mm Hg [-6.87 to 4.85]; P=0.73). Pre-specified adjusted analysis identified a significant interaction between treatment and baseline SBP (P interaction 0.003): participants with baseline SBP >160 mm Hg showed a greater response to tAN. No significant differences were observed for other secondary end points. tAN was safe and acceptable.

Conclusions: tAN is safe and well-tolerated in patients with hypertension. No significant BP-lowering effect was demonstrated, although a potential benefit in subgroups or a modest effect in a larger cohort cannot be excluded and warrants evaluation.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05179343. URL: XXX; Unique identifier: 14509154.

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无创经皮自主神经调节治疗未控制高血压的安全性、可接受性和有效性。

背景：尽管有降压药物治疗，仍有大约40%的高血压患者未能达到推荐血压（BP）目标。其他基于设备的策略通常是昂贵的或侵入性的。我们评估了一种无创经皮自主神经调节（tAN）装置的安全性、可接受性和潜在疗效。方法：scratchhtn（假对照随机试验，评估经皮迷走神经感觉刺激在未控制高血压患者中的自主神经调节的安全性、可接受性和有效性）是一项双盲、假对照、2a期试验，纳入未控制高血压患者（平均白天收缩压[SBP]≥135 mm Hg和舒张压≥85 mm Hg），服用一种或多种药物。参与者自我给予主动tAN或假治疗，每天30分钟，持续14天，然后每周10次。主要终点是安全性和可接受性。主要疗效终点是白天动态收缩压从基线到3个月的变化。次要终点包括1个月和3个月时的血压、心率和生活质量。结果：63例患者（平均年龄47.2岁，71.4%男性，平均白天血压150/95 mm Hg）随机分为2:1组。在3个月的白天动态收缩压方面，tAN与sham没有显著差异（组间差异为2.35 mm Hg [95% CI, -4.37至9.07]；P=0.49）或1个月（-1.01 mm Hg[-6.87至4.85]；P=0.73）。预先指定的调整分析确定了治疗与基线收缩压之间的显著相互作用（P相互作用为0.003）：基线收缩压bb0 160 mm Hg的参与者对tAN的反应更大。其他次要终点没有观察到显著差异。tAN是安全且可接受的。结论：坦在高血压患者中是安全且耐受性良好的。虽然不能排除在亚组中有潜在的益处或在更大的队列中有适度的效果，但没有显示出显著的降血压效果，值得评估。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT05179343。URL: XXX;唯一标识符：14509154。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hypertension 医学-外周血管病

CiteScore

15.90

自引率

4.80%

发文量

1006

审稿时长

1 months

期刊介绍： Hypertension presents top-tier articles on high blood pressure in each monthly release. These articles delve into basic science, clinical treatment, and prevention of hypertension and associated cardiovascular, metabolic, and renal conditions. Renowned for their lasting significance, these papers contribute to advancing our understanding and management of hypertension-related issues.