Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Hypertension, Blood Pressure, Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT06283758
- Run by
- Suzhou Municipal Hospital
- People needed
- 30
- Starts
- 2024-03-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)；
- 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;
- riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM)
- Regular night shift workers
- Individuals taking other medications that may affect blood pressure (such as glucocorticoids);
- Individual with history of kidney or kidney surrounding tissue surgery;
- Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference);
- 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 uncontrolled thyroid dysfunction;
- Individual with urinary calculi or hematuria；
- Individual with atrial fibrillation;
- 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 abnormal coagulation function;
- Individual with infected waist skin;
- Individual with claustrophobia；
- Individual with malignant tumor;
- History of allergy to amlodipine, olmesartan, and hydrochlorothiazide
- Individual is pregnant, nursing or planning to be pregnant;
- Individual is unwilling to sign informed consent;
- Individual fails to complete the screening period.
Where it is running
- The Affiliated Jiangning Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- The first Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)
- Suzhou Municipal Hospital — Suzhou, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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