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Clinical Trials in China / NCT06283758
Recruiting Not applicable

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)

NCT06283758 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Municipal Hospital
Phase
Not applicable
Started
2024-03-01
Last updated
2026-01-23

Condition(s) studied

HypertensionBlood PressureCardiovascular Diseases

Investigational drug(s) / intervention(s)

focused power ultrasound mediate inferior perirenal adipose tissue modificationSham-control group

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥130 mmHg; 3. The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm; 4. Individual is willing to sign the informed consent of the study. Exclusion Criteria: 1. 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); 2. 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; 3. riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM) 4. Regular night shift workers 5. Individuals taking other medications that may affect blood pressure (such as glucocorticoids); 6. Individual with history of kidney or kidney surrounding tissue surgery; 7. Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference); 8. Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment; 9. Individual with type 1 diabetes or uncontrolled type 2 diabetes; 10. Individual with uncontrolled thyroid dysfunction; 11. Individual with urinary calculi or hematuria; 12. Individual with atrial fibrillation; 13. Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease); 14. Individual with second degree and above atrioventricular block and/or sick sinus syndrome; 15. Individual with abnormal coagulation function; 16. Individual with infected waist skin; 17. Individual with claustrophobia; 18. Individual with malignant tumor; 19. History of allergy to amlodipine, olmesartan, and hydrochlorothiazide 20. Individual is pregnant, nursing or planning to be pregnant; 21. Individual is unwilling to sign informed consent; 22. Individual fails to complete the screening period.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
The Affiliated Jiangning Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
The first Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting
Suzhou Municipal Hospital Suzhou Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06283758 on ClinicalTrials.gov ↗ ← All trials in China