Focused Ultrasound Treatment of Fat Around Kidneys for High Blood Pressure
Tests focused ultrasound on fat near the kidneys in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)
Key facts
- Where
- Nanjing, Nantong, and Suzhou, ChinaSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06283758, who can take part
Where in China
- The Affiliated Jiangning Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
- Suzhou Municipal HospitalSuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Municipal Hospital
- Trial code
- NCT06283758
- Record updated
- 23 January 2026
- Original description
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.Read full original descriptionShow less
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Controlled Phase II/III Clinical Trial (PARADISE HTN-III)
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.
Inclusion: Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and <160 mmHg, and office diastolic blood pressure (DBP)<100mmHg after standardized antihypertensive drug treatment for 1 month; Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥130 mmHg；; The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；; Individual is willing to sign the informed consent of the study.
Exclusion: Individuals taking other medications that may affect blood pressure (such as glucocorticoids); 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)；; riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM); Individual with history of kidney or kidney surrounding tissue surgery; Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment; Individual with type 1 diabetes or uncontrolled type 2 diabetes；; Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease); Individual with second degree and above atrioventricular block and/or sick sinus syndrome; Individual with infected waist skin; Individual with malignant tumor; History of allergy to amlodipine, olmesartan, and hydrochlorothiazide; 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/L and/or impaired fasting glucose (6.1-6.9mmol/L); LDL-C ≥ 3.4mmol/L (130mg/dl), HDL-C<1.0mmol/L (40mg/dl) or TC ≥ 5.2mmol/L (200mg/dl); Family history of early onset of cardiovascular disease, age of onset of first degree relatives<50 years old; Abdominal obesity, waist circumference: male>90cm, female>85cm or BMI>28kg/m2) or hypertensive target organ damage; Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference); Regular night shift workers; Individual with uncontrolled thyroid dysfunction; Individual with urinary calculi or hematuria；; Individual with atrial fibrillation; Individual with abnormal coagulation function; Individual with claustrophobia；; Individual is pregnant, nursing or planning to be pregnant; Individual is unwilling to sign informed consent; Individual fails to complete the screening period.