Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)
Hypertension, Blood Pressure, Cardiovascular Diseases
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Cardiovascular disease, Focused ultrasound, Novel method
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical UniversityRecruiting
- The Affiliated Jiangning Hospital of Nanjing Medical UniversityRecruiting
- Suzhou Municipal HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
intervention group
sham-control group
In intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting and initiating) Intervention: Device: focused power ultrasound mediate inferior perirenal adipose tissue modification
In sham control group, participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment. Intervention: Device: sham-control group