Transcutaneous autonomic neuromodulation is being evaluated for its safety and efficacy in reducing daytime ambulatory systolic blood pressure in a phase 2a trial of 63 patients with uncontrolled hypertension.
RCT (n=63)
Double-blind
2:1 block randomization
Yes
Does transcutaneous autonomic neuromodulation reduce daytime ambulatory SBP in uncontrolled hypertensive patients on medication?
The SCRATCH-HTN study protocol outlines a phase 2a trial to evaluate transcutaneous autonomic neuromodulation as a non-invasive device-based treatment for uncontrolled hypertension.
Background Despite the broad availability of antihypertensive drugs, approximately 40% of hypertensive patients fail to achieve the recommended blood pressure (BP) levels and may require alternative treatment(s). At present, renal denervation is the only proven non-pharmacological device-based alternative treatment available, but it is a costly, invasive, hospital-based procedure that is unlikely to be widely available. Transcutaneous autonomic neuromodulation (tAN)—if shown to be safe, acceptable, and efficacious—can offer a non-invasive, inexpensive, self-administered device-based innovative adjunct or alternative to pharmacological therapy. Methods SCRATCH-HTN is a double-blind, sham-controlled trial, with 63 participants randomised on a 2:1 basis to receive either tAN or sham-tAN treatment. Hypertensive patients on medication were included if they had elevated systo-diastolic BPs on daytime ambulatory BP monitoring (ABPM) systolic BP (SBP) of ≥135 and 170 mmHg and mean daytime diastolic BP (DBP) of ≥85 and 115 mmHg. Participants were trained to self-administer tAN therapy for 30 min every day for first 14 days and then once a week for 10 weeks. The primary endpoint was change in daytime ambulatory SBP from baseline to 3 months. Secondary endpoints included change in 24-h ambulatory and office SBP and DBP, BP variability, heart rate variability, quality of life, and sleep quality from baseline to end of treatment. Other exploratory outcomes included evaluation of impact on functional exercise (6-min walk test), structural and functional changes in the heart, cognitive function, and central blood pressures. A subgroup of patients underwent detailed autonomic functional assessment at the start and end of the study. Conclusion The SCRATCH-HTN trial is a phase 2a study testing the safety, acceptability, and potential efficacy of tAN treatment for improving blood pressure control in patients with elevated BP despite medication. It also explores the effects of tAN on sleep, exercise tolerance, heart rate variability, central BP, cardiac structure, and autonomic function. If effective, it could offer a transformative approach to hypertension management. Study Protocol Registration Clinicaltrials.gov , identifier NCT05179343 and ISRCTN (14509154).
Gupta et al. (Wed,) conducted a rct in Uncontrolled hypertension (n=63). Transcutaneous autonomic neuromodulation (tAN) vs. Sham-tAN was evaluated on Change in average daytime ambulatory systolic blood pressure from baseline to 3 months. Transcutaneous autonomic neuromodulation is being evaluated for its safety and efficacy in reducing daytime ambulatory systolic blood pressure in a phase 2a trial of 63 patients with uncontrolled hypertension.