[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610852":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":36,"responsibleParty":54,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Shanghai Institute of Hypertension","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Perirenal adipose tissue modification by focused power ultrasound","EXPERIMENTAL","Perirenal adipose tissue modification (PRATM) by focused power ultrasound at both kidneys will be performed after the randomisation of eligible patients. After 1 month, if 24-h BP was uncontrolled and of at least 145\u002F100 mmHg, alisartan \u002Findapamide 240\u002F1.5mg once daily will be replaced by sacubitril alisartan 232\u002F248mg and indapamide 1.5mg once daily. At the 3-month after the treatment, if BP was uncontrolled, amlodipine will be uptitrated to 5mg twice a day. The duration of the follow-up after randomisation will be 6 months.",[13],"Procedure: Perirenal adipose tissue modification by focused power ultrasound",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham","SHAM_COMPARATOR","Sham procedure will be performed at both kidneys after the randomisation of eligible patients. After 1 month, if 24-h BP was uncontrolled and of at least 145\u002F100 mmHg, alisartan \u002Findapamide 240\u002F1.5mg once daily will be replaced by sacubitril alisartan 232\u002F248mg and indapamide 1.5mg once daily. At the 3-month after the treatment, if BP was uncontrolled, amlodipine will be uptitrated to 5mg twice a day. The duration of the follow-up after randomisation will be 6 months.",[19],"Procedure: Sham",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Perirenal adipose tissue modification by focused power ultrasound at both kidneys",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Sham procedure of focused ultrasound at both kidneys",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Yan Li, Professor","CONTACT","021-64370045","675101","liyanshcn@163.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Ruijin Hospital","Shanghai","Shanghai Municipality","200025","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51,52],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":31,"role":53,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Yan Li","Professor, Doctor of Medicine, Doctor of Philosophy","100610852","phase-3-perirenal-adipose-tissue-modification-therapy-for-resistant-hypertension-100610852",false,"NCT07232966","Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension","The Efficacy and Safety of Perirenal Adipose Tissue Modification Therapy by Focused Power Ultrasound for Resistant Hypertension","PATH-RHT","Inclusion Criteria:\n\n1. Male or female participants aged 18-75 years old;\n2. 24h ambulatory systolic BP ≥130mmHg and \\\u003C150mmHg, and 24h ambulatory diastolic BP \\\u003C100mmHg after at least 4 weeks of combined treatment with 3 antihypertensive drugs (including a diuretic);\n3. The ultrasound measured inferior perirenal adipose tissue ≥8 cm3 (with the superior-inferior diameter, left-right diameter, and anterior-posterior diameter all needing to be ≥20 mm);\n4. Be willing to participate in the trial, and be able to visit doctors by himself or herself;\n5. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Secondary hypertension;\n2. Occurrence of myocardial infarction, malignant arrhythmia, severe renal failure, or stroke within 6 months;\n3. Ambulatory BP monitoring was invalid (\\\u003C70% valid readings, or \\\u003C20 daytime readings or \\\u003C7 nighttime readings);\n4. Alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin (TBL) above twice the normal range; eGFR (CKD-EPI) \\\u003C45mL\u002Fmin\u002F1.73m2;\n5. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (glycated hemoglobin ≥8.5%);\n6. Single functionally normal kidney or presence of renal malignant tumor;\n7. Bilateral skin diseases at renal region that are not suitable for the therapy;\n8. Women in pregnancy, lactating, or planning for pregnancy;\n9. Other concomitant diseases that are considered not suitable for participation in the trial;\n10. Patients have contraindications to angiotensin receptor-neprilysin inhibitor (ARNIs), thiazide-like diuretic drugs, or calcium channel blocker (CCBs);\n11. Non-compliant patients.","ALL","18 Years","75 Years",{"count":70,"type":71},220,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","The goal of this clinical trial is to investigate if focused power ultrasound (FPU) targeted perirenal adipose tissue modification therapy would be effective and safe in treating resistant hypertension. The primary outcome of the study is the difference in the reduction of 24h mean systolic blood pressure between treatment and sham procedure groups 6 months after treatment. The secondary outcomes include the reduction of clinic blood pressure 1, 3, and 6 months after treatment, the reduction of 24h mean blood pressure 1, 3, and 6 months after treatment, and the drug burden of antihypertensive treatment. The safety evaluation includes the incidence of all-cause death, cardiovascular events (stroke and myocardial infarction), renal failure, and other adverse events.",[77],"Resistant Hypertension",[79,80],"perirenal adipose tissue","focused ultrasound","NOT_YET_RECRUITING","2025-11-14",{"date":84,"type":85},"2025-11-18","ACTUAL",{"date":87,"type":71},"2025-11-20",{"date":89,"type":71},"2029-06-30",{"name":56,"class":6},1]