[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537894":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":113,"collaborators":115,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":31,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":31,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Suzhou Municipal Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Stage 1: Intervention group","EXPERIMENTAL","This arm is combined with 3 groups and a total of 30 participants will be 1:1:1 allocated (each group with 10 participants).\n\nSingle treatment group: receive treatment once after enrollment; Consecutive treatment group A: receive 3 consecutive treatments, each with an interval of 3 days; Consecutive treatment group B: receive 3 consecutive treatments, each with an interval of 7 days. In Stage 1, the investigators will select optimal treatment strategy and proceed to Stage 2.",[13],"Device: focused power ultrasound mediate inferior perirenal adipose tissue modification",{"label":15,"type":16,"description":17,"interventionNames":18},"Stage 2: Intervention group","ACTIVE_COMPARATOR","Participants will receive optimal treatment strategy selected formerly in Stage 1",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Stage 2: Sham-control group","SHAM_COMPARATOR","In sham control group, 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.",[24],"Device: Sham-control group",[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","focused power ultrasound mediate inferior perirenal adipose tissue modification","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.",[9,15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Sham-control group","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.",[20],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Yanhui Sheng","CONTACT","13851647530","yhsheng@njmu.edu.cn",{"name":43,"role":39,"phone":44,"phoneExt":31,"email":45},"Yang Hua","13851624359","759150674@qq.com",[47,70,85,101],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"The Affiliated Jiangning Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":56,"coordinates":57},"Point",[58,59],118.77778,32.06167,{"lat":59,"lon":58},[62,65,68],{"name":63,"role":39,"phone":64,"phoneExt":31,"email":31},"Yuqing Zhang","13851672168",{"name":66,"role":39,"phone":67,"phoneExt":31,"email":31},"Qin Tao","1585062208",{"name":63,"role":69,"phone":31,"phoneExt":31,"email":31},"PRINCIPAL_INVESTIGATOR",{"facility":71,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"The first Affiliated Hospital of Nanjing Medical University",{"type":56,"coordinates":73},[58,59],{"lat":59,"lon":58},[76,80,84],{"name":77,"role":39,"phone":78,"phoneExt":31,"email":79},"Fang Zhou","13815401066","zhoufang7408@163.com",{"name":81,"role":39,"phone":82,"phoneExt":31,"email":83},"Wei Sun","13815860536","shunwee@126.com",{"name":77,"role":69,"phone":31,"phoneExt":31,"email":31},{"facility":86,"status":49,"city":87,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Affiliated Hospital of Nantong University","Nantong",{"type":56,"coordinates":89},[90,91],120.87472,32.03028,{"lat":91,"lon":90},[94,97,100],{"name":95,"role":39,"phone":96,"phoneExt":31,"email":31},"Hongzhuan Sheng","13515203348",{"name":98,"role":39,"phone":99,"phoneExt":31,"email":31},"Jian Zhuo","18206297131",{"name":95,"role":69,"phone":31,"phoneExt":31,"email":31},{"facility":5,"status":49,"city":102,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Suzhou",{"type":56,"coordinates":104},[105,106],120.59538,31.30408,{"lat":106,"lon":105},[109,111,112],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":110},"yhshengnjmu@163.com",{"name":43,"role":39,"phone":44,"phoneExt":31,"email":45},{"name":38,"role":69,"phone":31,"phoneExt":31,"email":31},{"type":69,"investigatorFullName":38,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Professor in Department of Cardiovascular medicine",[116,117,119],{"name":48,"class":6},{"name":118,"class":6},"The First Affiliated Hospital with Nanjing Medical University",{"name":86,"class":6},"100537894","focused-power-ultrasound-mediated-inferior-perirenal-adipose-tissue-modification-therapy-for-essential-hypertension-paradise-htn-iii-100537894",false,"NCT06283758","Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)","Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Controlled Phase II\u002FIII Clinical Trial (PARADISE HTN-III)","Inclusion Criteria:\n\n1. Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and \\\u003C160 mmHg, and office diastolic blood pressure (DBP)\\\u003C100mmHg after standardized antihypertensive drug treatment for 1 month;\n2. Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥130 mmHg；\n3. The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；\n4. Individual is willing to sign the informed consent of the study.\n\nExclusion Criteria:\n\n1. Individual diagnosed as secondary hypertension (e.g. renal parenchymal hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, aortic coarctation, obstructive sleep apnea hypopnea syndrome)；\n2. Individuals with ≥ 3 cardiovascular risk factors (male\\>55 years old, female\\>65 years old; smoking or passive smoking; 2-hour postprandial blood glucose 7.8-11mmol\u002FL and\u002For impaired fasting glucose (6.1-6.9mmol\u002FL); LDL-C ≥ 3.4mmol\u002FL (130mg\u002Fdl), HDL-C\\\u003C1.0mmol\u002FL (40mg\u002Fdl) or TC ≥ 5.2mmol\u002FL (200mg\u002Fdl); Family history of early onset of cardiovascular disease, age of onset of first degree relatives\\\u003C50 years old; Abdominal obesity, waist circumference: male\\>90cm, female\\>85cm or BMI\\>28kg\u002Fm2) or hypertensive target organ damage;\n3. riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM)\n4. Regular night shift workers\n5. Individuals taking other medications that may affect blood pressure (such as glucocorticoids);\n6. Individual with history of kidney or kidney surrounding tissue surgery;\n7. Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference);\n8. Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;\n9. Individual with type 1 diabetes or uncontrolled type 2 diabetes；\n10. Individual with uncontrolled thyroid dysfunction;\n11. Individual with urinary calculi or hematuria；\n12. Individual with atrial fibrillation;\n13. Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease);\n14. Individual with second degree and above atrioventricular block and\u002For sick sinus syndrome;\n15. Individual with abnormal coagulation function;\n16. Individual with infected waist skin;\n17. Individual with claustrophobia；\n18. Individual with malignant tumor;\n19. History of allergy to amlodipine, olmesartan, and hydrochlorothiazide\n20. Individual is pregnant, nursing or planning to be pregnant;\n21. Individual is unwilling to sign informed consent;\n22. Individual fails to complete the screening period.","ALL","18 Years","65 Years",{"count":131,"type":132},30,"ESTIMATED","INTERVENTIONAL",[135],"NA","This seamless two-stage phase II\u002FIII 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.",[138,139,140],"Hypertension","Blood Pressure","Cardiovascular Diseases",[138,142,143,144],"Cardiovascular diseases","Focused ultrasound","Novel method","2026-01-21",{"date":147,"type":148},"2026-01-23","ACTUAL",{"date":150,"type":148},"2024-03-01",{"date":152,"type":132},"2026-10",{"name":5,"class":6},4]