Fact CheckerSign in

NCT06018493Completed

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

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Drug Naive Randomized Controlled Trial (PARADISE-HTN-II)

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.

Status (registry)
Completed
Study type
Interventional
Enrollment
79 (actual)
First submitted
25 Aug 2023
Start date
1 Sept 2023
Primary completion date
12 Feb 2025
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06018493

What you commit to

  • Study type: Interventional
  • Participants enrolled: 79
  • From 1 Sept 2023 to the primary completion date, 12 Feb 2025
  • 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);
  • 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;

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

  • Individual with office systolic blood pressure (SBP) ≥ 160 mmHg and/or office diastolic blood pressure(DBP)≥ 100mmHg;
  • Individual with uncontrolled thyroid dysfunction;
  • Individual with urinary calculi or hematuria;
  • Individual with atrial fibrillation;
  • Individual with abnormal coagulation function;
  • 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 diastolic blood pressure\<100mmHg when not taking antihypertensive drugs for at least 1 month;
  • Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥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 First People's Hospital Of Changzhou
Coordinator of this site? Confirm its status
ChangzhouChinaUnknown status
The Affiliated Jiangning Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Suzhou Municipal Hospital
Coordinator of this site? Confirm its status
SuzhouChinaUnknown status

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