Focused ultrasound treatment for high blood pressure

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)

This study is testing a new ultrasound treatment that aims to lower blood pressure by targeting fat around the kidneys in people with high blood pressure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Suzhou Municipal Hospital (other)
• Locations: 4 sites (Nanjing, Jiangsu and 3 other locations)
• Trial ID: NCT06283758 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a novel focused power ultrasound therapy aimed at modifying inferior perirenal adipose tissue to treat essential hypertension. It consists of two stages: the first is a phase II trial to identify the optimal treatment strategy, while the second is a phase III trial comparing the efficacy and safety of this strategy against a sham control. The study is based on the premise that reducing perirenal fat can help control blood pressure and reduce cardiovascular risks. Previous studies have shown the feasibility and safety of this approach in humans and animals.

Who should consider this trial

Good fit: Ideal candidates are individuals with essential hypertension who have specific blood pressure readings and sufficient perirenal fat as measured by ultrasound.

Not a fit: Patients with secondary hypertension or multiple cardiovascular risk factors may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this therapy could provide a new, non-invasive treatment option for patients with essential hypertension.

How similar studies have performed: While this approach is novel, preliminary studies have shown promising results in modifying perirenal adipose tissue using focused ultrasound.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu and 3 other locations

• The Affiliated Jiangning Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
• The first Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (RECRUITING)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Yanhui Sheng

Conditions: Hypertension, Blood Pressure, Cardiovascular Diseases, Cardiovascular diseases, Focused ultrasound, Novel method