NCT06283758Recruiting
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/III Clinical Trial (PARADISE HTN-III)
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Suzhou Municipal Hospital
- Diseases
- High blood pressure
- NCT number
- NCT06283758
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Mar 2024 to the primary completion date, Jul 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals taking other medications that may affect blood pressure (such as glucocorticoids);
Other illness
- 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
Lab values
- 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);
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Jiangning Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.