Focused ultrasound treatment for high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yhsheng@njmu.edu.cn
• Phone: 13851647530

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.