nctId: NCT06283758 id: PARADISE HTN-III briefTitle: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-07 date: 2026-10 date: 2024-02-28 date: 2024-03-04 name: Suzhou Municipal Hospital class: OTHER name: The Affiliated Jiangning Hospital of Nanjing Medical University name: The First Affiliated Hospital with Nanjing Medical University name: Affiliated Hospital of Nantong University briefSummary: This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control. conditions: Hypertension conditions: Blood Pressure conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: focused power ultrasound mediate inferior perirenal adipose tissue modification name: Sham-control group measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Office Systolic Blood Pressure measure: Office Systolic Blood Pressure measure: Ambulatory Blood Pressure measure: Ambulatory Blood Pressure measure: Home Blood Pressure measure: Home Blood Pressure measure: Blood pressure control rate measure: Antihypertensive drug load index measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Jiangning Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Yuqing Zhang role: CONTACT phone: 13851672168 name: Qin Tao role: CONTACT phone: 1585062208 name: Yuqing Zhang role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: The first Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China name: Fang Zhou role: CONTACT phone: 13815401066 email: zhoufang7408@163.com name: Wei Sun role: CONTACT phone: 13815860536 email: shunwee@126.com name: Fang Zhou role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 facility: Affiliated Hospital of Nantong University city: Nantong state: Jiangsu zip: 210000 country: China name: Hongzhuan Sheng role: CONTACT phone: 13515203348 name: Jian Zhuo role: CONTACT phone: 18206297131 name: Hongzhuan Sheng role: PRINCIPAL_INVESTIGATOR lat: 32.03028 lon: 120.87472 facility: Suzhou Municipal Hospital city: Suzhou state: Jiangsu zip: 210000 country: China name: Yanhui Sheng role: CONTACT phone: 13851647530 email: yhshengnjmu@163.com name: Yang Hua role: CONTACT phone: 13851624359 email: 759150674@qq.com name: Yanhui Sheng role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False