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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
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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Affiliated Jiangning Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Affiliated Hospital of Nantong University
Coordinator of this site? Confirm its status
NantongChinaRecruiting
Suzhou Municipal Hospital
Coordinator of this site? Confirm its status
SuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.