Focused ultrasound treatment for high blood pressure

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

This study is testing a new ultrasound treatment that aims to reduce belly fat around the kidneys to see if it can help people with high blood pressure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 4 sites (Changzhou, Jiangsu and 3 other locations)
• Trial ID: NCT06018493 on ClinicalTrials.gov

What this trial studies

This randomized, blinded, sham-controlled trial evaluates the efficacy and safety of a novel focused power ultrasound technique aimed at modifying inferior perirenal adipose tissue to treat essential hypertension. The study is based on the understanding that visceral fat, particularly peri-renal fat, plays a significant role in hypertension and cardiovascular diseases. Previous experiments have shown that this ultrasound method can effectively promote tissue changes and control blood pressure in animal models, and initial human studies suggest it is feasible and safe. The trial will further assess these outcomes in a larger group of participants.

Who should consider this trial

Good fit: Ideal candidates are individuals with systolic blood pressure between 140-160 mmHg and diastolic blood pressure below 100 mmHg who have not taken antihypertensive medications for at least one month.

Not a fit: Patients with secondary hypertension or those with significantly elevated blood pressure (≥ 160 mmHg) will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for managing high blood pressure in patients.

How similar studies have performed: While this approach is novel, preliminary studies have shown promise in modifying perirenal fat and controlling blood pressure, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥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 with office systolic blood pressure (SBP) ≥ 160 mmHg and/or office diastolic blood pressure(DBP)≥ 100mmHg;
2. 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)；
3. 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;
4. Individuals taking other medications that may affect blood pressure (such as glucocorticoids);
5. Individual with history of kidney or kidney surrounding tissue surgery;
6. Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference);
7. Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
8. Individual with type 1 diabetes or uncontrolled type 2 diabetes；
9. Individual with uncontrolled thyroid dysfunction;
10. Individual with urinary calculi or hematuria；
11. Individual with atrial fibrillation;
12. Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease);
13. Individual with second degree and above atrioventricular block and/or sick sinus syndrome;
14. Individual with abnormal coagulation function;
15. Individual with infected waist skin;
16. Individual with malignant tumor;
17. Individual is pregnant, nursing or planning to be pregnant;
18. Individual is unwilling to sign informed consent;
19. Individual fails to complete the screening period.

Where this trial is running

Changzhou, Jiangsu and 3 other locations

• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (Recruiting)
• Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• The Affiliated Jiangning Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiangqing Kong

Conditions Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular disease; Focused ultrasound; Novel method