TOPLINE

Among patients with uncontrolled hypertension, transcutaneous autonomic neuromodulation (tAN) appeared safe but did not significantly lower daytime systolic blood pressure (BP) compared with stimulation delivered via a sham device; however, tAN showed a possible benefit among those with very high systolic BP at baseline.

METHODOLOGY

• Researchers in London conducted a double-blind phase 2a trial to assess the safety, acceptability, and potential efficacy of tAN in patients with uncontrolled hypertension (average daytime ambulatory systolic BP ≥ 135 and < 170 mm Hg; diastolic BP ≥ 85 and < 115 mm Hg).
• A total of 63 adults with uncontrolled hypertension who were taking antihypertensive medications were included (mean age, 47.2 years; 71.4% men; mean baseline daytime ambulatory BP, 150/95 mm Hg).
• The patients were randomly assigned to receive either active stimulation via a tAN device or no stimulation via an identical sham device. The patients placed electrode clips in front of each ear canal and self-administered stimulations for 30 minutes daily for 14 days and then once weekly for 10 weeks; their medicines for BP remained unchanged throughout the period.
• The primary efficacy endpoint was the change in average daytime ambulatory systolic BP from baseline to 3 months. Secondary efficacy endpoints included changes in 24-hour and office BP, heart rate, and quality of life from baseline to 1 and 3 months.
• Researchers also assessed the safety of the device and patients’ adherence to treatment.

TAKEAWAY

• At 3 months, daytime ambulatory systolic BP reduced by 3.15 mm Hg among patients who received tAN and by 5.50 mm Hg among those who received sham treatment. The difference between the groups was not statistically significant.
• Diastolic BP, 24-hour and office BP, heart rate, quality of life, and 6-minute walk test distance at 1 and 3 months did not differ significantly between patients who received tAN and those who received sham treatment.
• In a subgroup analysis, patients with baseline systolic BP ≥ 160 mm Hg had a greater reduction of 12.73 mm Hg with tAN than with sham treatment. The interaction between treatment and baseline systolic BP was significant (P = .003), and the finding was considered exploratory.
• The median adherence was 100% in both arms. Effects related to the stimulation were mild or moderate, and no serious adverse events were attributed to it.

IN PRACTICE

"[The] findings demonstrate that tAN, as delivered in this study, does not exert a strong measurable antihypertensive effect in broadly representative, uncontrolled hypertensive patients on treatment," the researchers wrote. "[The] findings validate patient acceptability and suggest that, should future efficacy be established in selected populations, implementation would likely be feasible at scale," they added.

SOURCE

The study was led by Ajay Gupta, MD, PhD, of Queen Mary University of London, London, England. It was published online on September 28 in Hypertension.

LIMITATIONS

The trial lacked sufficient power to detect differences between groups, which was further limited by the pronounced response in the sham arm. Stimulation was reduced from daily to once weekly after 14 days, which may have reduced any lasting effect. Some participants changed their BP medications during the trial.

DISCLOSURES

The study received funding from the National Institute for Health and Care Research. The authors acknowledged support from the sponsor Queen Mary University of London. The device manufacturer, Afferent Medical Solutions, supported the regulatory aspects of the device. One author reported receiving personal consulting fees, institutional grants, honoraria, and advisory board roles with multiple pharmaceutical and medical device companies. Another author reported serving as a director of two companies. Detailed disclosures are available in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.