This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control.
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;
Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥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.
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;
riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM)
Regular night shift workers
Parallel
focused power ultrasound mediate inferior perirenal adipose tissue modification
DeviceThis 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.
Sham-control group
DeviceParticipants 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.
Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline
Office Systolic Blood Pressure
Changes of office systolic blood pressure at 1-month compared with baseline
Office Systolic Blood Pressure
Changes of office systolic blood pressure at 3-month compared with baseline
Ambulatory Blood Pressure
Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Incidence of adverse events
Any adverse events (AE) or severe adverse events (SAE) related to intervention. The SAE were defined as acute renal failure, acute intestinal perforation, and thromboembolic events, et al.
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Suzhou Municipal Hospital
Lead sponsor
The Affiliated Jiangning Hospital of Nanjing Medical University
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
