Essential Hypertension
Conditions
Interventions
Experimental group:Standard antihypertensive drug therapy + focused power ultrasound mediated bilateral inferior perirenal fat modification therapy (FPU-iPRATM) once with energy release
Control group:Standard antihypertensive drug therapy + focused power ultrasound mediated bilateral inferior perirenal fat modification therapy (FPU-iPRATM) once, without energy release
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years, regardless of gender; 2. Clear history of primary hypertension for at least 6 months; 3. Poor blood pressure control after at least 4 weeks of treatment with 1 to 3 stable doses of antihypertensive medications, with participants voluntarily agreeing to participate in the study and signing informed consent; subsequently, they undergo a standard antihypertensive medication treatment during the lead-in period for at least 4 weeks, with medication adherence >=80%, office systolic blood pressure (OSBP) between 140 mmHg and 159 mmHg, office diastolic blood pressure (ODBP) =130 mmHg; 4. Participants have good compliance and are willing to complete clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Anatomical structure of fat at the lower pole of the kidney is not suitable for treatment: (1) Ultrasound measurement shows the left-right diameter of the fat at either lower pole of the kidney is 13cm; Definition of target skin distance: the straight-line distance from the skin entry point of the ultrasound beam on the treatment side of the waist to the perirenal fat target area at the lower pole of the same kidney when the subject is in the standard lateral decubitus treatment position. 2. 24-hour ASBP 2 × upper limit of normal (ULN), or eGFR 1.5; 7. During run-in period, using antihypertensive drugs other than standardized antihypertensive drugs; 8. History or current presence of any of the following conditions: (1) Essential pulmonary arterial hypertension; (2) Secondary hypertension due to renal parenchymal disease, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing’s syndrome, aortic coarctation, hyperthyroidism, or hyperparathyroidism; (3) Type 1 diabetes mellitus or poorly controlled type 2 diabetes (HbA1c >=8.0%); (4) Severe structural heart disease (e.g., significant valvular stenosis, Tetralogy of Fallot) contraindicating or intolerant to substantial BP reduction; (5) Severe arrhythmias, including second-degree type II or higher atrioventricular block and/or sick sinus syndrome, or atrial fibrillation requiring anticoagulation; (6) Myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months before screening; (7) Planned major surgery or cardiovascular intervention within 6 months; (8) Any condition that may interfere with accurate BP measurement (e.g., severe peripheral arterial disease, abdominal aortic aneurysm, thrombocytopenia, hemophilia, or severe anemia); (9) Polycystic kidney disease, solitary kidney, or prior renal or perirenal surgery; (10) Alcohol abuse or unknown drug dependence history; (11) Known hypersensitivity to amlodipine, valsartan, hydrochlorothiazide, or similar antihypertensive drugs; (12) History of malignancy with life expectancy <1 year; (13) Psychiatric disorders such as depression or anxiety; 9. Participation in another clinical trial (drug or device) within 3 months prior to screening; 10. Obstructive sleep apnea–hypopnea syndrome requiring chronic oxygen therapy or mechanical ventilation; 11. Pregnant or breastfeeding women, or those intending to become pregnant during the study period; 12. Poor adherence or inability to comply with study procedures as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control rate of blood pressure (Office blood pressure<140/90mmHg);Composite index of antihypertensive drugs;Serious advent events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean 24-h ambulatory systolic blood pressure;Mean 24-h ambulatory diastolic blood pressure;Office BP;Composite index of antihypertensive drugs;Control rate of blood pressure (Office blood pressure<140/90mmHg); | — |
Countries
China
Contacts
Public ContactJing Liu
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed