This randomized, double blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
The increase of visceral fat is closely related to the occurrence of hypertension, and it is one of the main independent risk factors of hypertension. Visceral fat has been recognized as an important endocrine organ, and a variety of factors secreted by visceral fat lead to an increased risk of cardiovascular disease. Peri-renal fat is a special type of visceral fat which is different from other type of visceral fat in histology, physiology, and functions. The positon of peri-renal fat is more stable than other visceral fat, which might be influenced by breath or body position changes.Studies have found that perirenal fat is an early predictor of ASCVD, and its accumulation is closely related to the occurrence and development of ASCVD.Therefore, the reduction or modification of visceral fat,especially peri-renal fat , has a sufficient scientific basis for the treatment of hypertension. In our previous experiments, this novel focused power ultrasound can rapidly and efficiently promote the perirenal adipse tissue fibrosis and control the blood pressure in the model of swine. Moreover, we performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior perirenal adipose tissue in human volunteers, showing that this kind of method was feasible and safe. In this study, we aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
103
This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.
participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.
Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Office Systolic Blood Pressure
Changes of office systolic blood pressure at 1-month compared with baseline
Time frame: From baseline to 1 month post-procedure
Office Systolic Blood Pressure
Changes of office blood pressure at 3-month compared with baseline
Time frame: From baseline to 3 months post-procedure
Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Time frame: From baseline to 1 month post-procedure
Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline
Time frame: From baseline to 3 months post-procedure
Heart Rate
Changes of the heart rate at 1-month compared with baseline
Time frame: From baseline to 1 month post-procedure
Mean Heart Rate
Changes of the mean heart rate measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Time frame: From baseline to 1 month post-procedure
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