Status:
RECRUITING
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
The Affiliated Jiangning Hospital of Nanjing Medical University
Suzhou Municipal Hospital
Conditions:
Hypertension
Blood Pressure
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The increase of visceral fat is closely related to the occurrence of hypertension, and it is one of the main independent risk factors of hypertension. Visceral fat has been recognized as an important ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Individual with office systolic blood pressure (SBP) ≥ 160 mmHg and/or office diastolic blood pressure(DBP)≥ 100mmHg;
- 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;
- 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 malignant tumor;
- Individual is pregnant, nursing or planning to be pregnant;
- Individual is unwilling to sign informed consent;
- Individual fails to complete the screening period.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06018493
Start Date
September 1 2023
End Date
December 1 2025
Last Update
May 4 2025
Active Locations (4)
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1
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
2
Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
3
The Affiliated Jiangning Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
4
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000