protocolSection identificationModule nctId: NCT06283758, orgStudyIdInfo id: PARADISE HTN-III, briefTitle: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Suzhou Municipal Hospital, class: OTHER, collaborators name: The Affiliated Jiangning Hospital of Nanjing Medical University, collaborators name: The First Affiliated Hospital with Nanjing Medical University, collaborators name: Affiliated Hospital of Nantong University, descriptionModule 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., conditionsModule conditions: Hypertension, conditions: Blood Pressure, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: focused power ultrasound mediate inferior perirenal adipose tissue modification, interventions name: Sham-control group, outcomesModule primaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Office Systolic Blood Pressure, secondaryOutcomes measure: Office Systolic Blood Pressure, secondaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Ambulatory Blood Pressure, secondaryOutcomes measure: Home Blood Pressure, secondaryOutcomes measure: Home Blood Pressure, secondaryOutcomes measure: Blood pressure control rate, secondaryOutcomes measure: Antihypertensive drug load index, otherOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Affiliated Jiangning Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Yuqing Zhang, role: CONTACT, phone: 13851672168, contacts name: Qin Tao, role: CONTACT, phone: 1585062208, contacts name: Yuqing Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The first Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Fang Zhou, role: CONTACT, phone: 13815401066, email: zhoufang7408@163.com, contacts name: Wei Sun, role: CONTACT, phone: 13815860536, email: shunwee@126.com, contacts name: Fang Zhou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Affiliated Hospital of Nantong University, city: Nantong, state: Jiangsu, zip: 210000, country: China, contacts name: Hongzhuan Sheng, role: CONTACT, phone: 13515203348, contacts name: Jian Zhuo, role: CONTACT, phone: 18206297131, contacts name: Hongzhuan Sheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.03028, lon: 120.87472, locations facility: Suzhou Municipal Hospital, city: Suzhou, state: Jiangsu, zip: 210000, country: China, contacts name: Yanhui Sheng, role: CONTACT, phone: 13851647530, email: yhshengnjmu@163.com, contacts name: Yang Hua, role: CONTACT, phone: 13851624359, email: 759150674@qq.com, contacts name: Yanhui Sheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False