Abstract
Perirenal adipose tissue (PRAT) contributes to the maintenance of elevated blood pressure through afferent nerves and serves as an important peripheral, modifiable target for hypertension management. This single-center, prospective pilot trial assessed the feasibility and safety of a novel focused power ultrasound device for perirenal adipose tissue modification (PRATM) therapy in essential hypertension. Twenty patients (mean age 47.5 ± 11.0 years, 85% male) with office systolic blood pressure (OSBP) 140-180 mmHg or diastolic blood pressure (ODBP) ≥90 mmHg were enrolled. All underwent PRATM therapy and were followed for 3 months. The primary endpoint was all-cause mortality or device-related adverse events (AEs). Four patients experienced transient mild lumbar pain, and one had mild skin redness, all resolving spontaneously. No serious AEs or clinically significant abnormalities were observed. OSBP decreased by 14.6 mmHg at 1 month and 18.2 mmHg at 3 months; ODBP decreased by 5.8 mmHg and 2.8 mmHg, respectively. For the 24-hour ambulatory blood pressure monitoring (ABPM), 24-hour ambulatory SBP decreased by 3.6 mmHg (95% CI: -3.6-10.8 mmHg) and 24-hour ambulatory DBP decreased by 2.2 mmHg (95% CI: -2.7-7.0 mmHg) at 1 month. At 3 months, 24-hour ambulatory SBP decreased by 2.8 mmHg (95% CI: -5.4-11.0 mmHg) and 24-hour ambulatory DBP decreased by 1.7 mmHg (95% CI: -4.0-7.3 mmHg). PRATM shows preliminary feasibility and safety, but larger, randomized trials are needed for definitive efficacy and long-term safety validation.