Blood Pressure, Cardiovascular Diseases, Hypertension
Conditions
Keywords
Hypertension, Cardiovascular disease, Focused ultrasound, Novel method
Brief summary
This randomized, double 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 hypertension.
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 endocrine organ, and a variety of factors secreted by visceral fat lead to an increased risk of cardiovascular disease. Peri-renal fat is a special type of visceral fat which is different from other type of visceral fat in histology, physiology, and functions. The positon of peri-renal fat is more stable than other visceral fat, which might be influenced by breath or body position changes.Studies have found that perirenal fat is an early predictor of ASCVD, and its accumulation is closely related to the occurrence and development of ASCVD.Therefore, the reduction or modification of visceral fat,especially peri-renal fat , has a sufficient scientific basis for the treatment of hypertension. In our previous experiments, this novel focused power ultrasound can rapidly and efficiently promote the perirenal adipse tissue fibrosis and control the blood pressure in the model of swine. Moreover, we performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior perirenal adipose tissue in human volunteers, showing that this kind of method was feasible and safe. In this study, we aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.
Interventions
DEVICEfocused power ultrasound mediate inferior perirenal adipose tussue modification
This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small cigar-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.
DEVICEsham-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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The masking range includes participants, most researchers (including the study leader; subjects screening researchers; follow-up researchers; sonographers; MR scanners, members of the clinical endpoint identification committee,and etc.) except for the study statistical analysts and the therapy operators
Intervention model description
This is a ramdomized, double-blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Individual has office systolic blood pressure (SBP) ≥ 140 mmHg and \<180 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes； 2. Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 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 is 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. Individual has history of kidney and or kidney surrounding tissue surgery; 3. Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference); 4. Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment; 5. Individual has type 1 diabetes or poorly-controlled type 2 diabetes； 6. Individual has uncontrolled thyroid dysfunction; 7. Individual has urinary calculi and/or hematuria； 8. Individual has atrial fibrillation; 9. Individual has severe structural heart disease (e.g. heart valve disease, cardiomyopathy, congenital heart disease); 10. Individual has second degree and above atrioventricular block； 11. Individual has abnormal coagulation function; 12. Individual has infected waist skin; 13. Individual has malignant tumor; 14. Individual is pregnant, nursing or planning to be pregnant; 15. Individual is unwilling to sign informed consent; 16. Individual fails to complete the screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Office Systolic Blood Pressure | From baseline to 1 month post-procedure | Changes of office systolic blood pressure at 1-month compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Office Systolic Blood Pressure | From baseline to 3 months post-procedure | Changes of office blood pressure at 3-month compared with baseline |
| Ambulatory Blood Pressure | From baseline to 1 month post-procedure | Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline |
| Heart Rate | From baseline to 1 month post-procedure | Changes of the heart rate at 1-month compared with baseline |
| Mean Heart Rate | From baseline to 1 month post-procedure | Changes of the mean heart rate measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | From baseline to 1 month post-procedure | Any severe adverse events (SAE) related to intervention. The SAE were defined as acute renal failure, acute intestinal perforation, and thromboembolic events, et al. |
Countries
China
Outcome results
None listed