Hypertension
Conditions
Interventions
Treatment Group:This clinical trial utilizes the Darwin Type 1 focused ultrasound treatment system (developed by Nanjing Khons Medical Technology Co., Ltd., not yet marketed) to intervene on the bilat
Control Group:In this clinical trial, the control group received simulated focused ultrasound treatment. The treatment system was set to a mode that does not actually emit therapeutic ultrasound (i.e.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years, inclusive. (2) Diagnosed with hypertension, having not taken any antihypertensive medications for at least 30 days, and with office blood pressure failing to meet the target. Target standard: resting office blood pressure = 130 mmHg. (4) The subject voluntarily agrees to participate in the study and has signed the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: (1) Unsuitable perirenal fat anatomy at the lower pole of the kidney for this study treatment: 1) Ultrasound measurement shows the left-right diameter of the perirenal fat at the lower pole of either kidney is 13 cm.** *Lateral decubitus target-skin distance: The linear distance from the ultrasound beam entry point on the lateral waist skin to the target area (perirenal fat at the lower pole of the ipsilateral kidney) while the subject is in the standard lateral decubitus treatment position. (2) Presence of skin breakdown, redness, swelling, local infection, or sensory impairment in the lumbar region. (3) History of surgery involving the kidneys and/or surrounding tissues. (4) Presence of urinary system stones and/or hematuria (gross hematuria or positive occult blood). (5) Estimated Glomerular Filtration Rate (eGFR) 2 times the upper limit of normal). (14) Uncontrolled thyroid dysfunction. (15) Coagulation disorders (International Normalized Ratio, INR > 1.5). (16) History of malignant tumors. (17) Pregnant women, those who are breastfeeding, or those planning to become pregnant. (18) Concurrent participation in other clinical trials, or any other condition deemed by the investigator as unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour average systolic blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour average systolic blood pressure;24-hour average diastolic blood pressure;Clinic blood pressure control rate; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital, Fudan University
Outcome results
None listed