Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Double-blinded Controlled Trial. PARADISE Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 103
- Locations
- 3
- Primary Endpoint
- Office Systolic Blood Pressure
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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；
- •Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 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 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)；
- •Individual has history of kidney and or kidney surrounding tissue surgery;
- •Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference);
- •Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
- •Individual has type 1 diabetes or poorly-controlled type 2 diabetes；
- •Individual has uncontrolled thyroid dysfunction;
- •Individual has urinary calculi and/or hematuria；
- •Individual has atrial fibrillation;
- •Individual has severe structural heart disease (e.g. heart valve disease, cardiomyopathy, congenital heart disease);
- •Individual has second degree and above atrioventricular block；
Outcomes
Primary Outcomes
Office Systolic Blood Pressure
Time Frame: From baseline to 1 month post-procedure
Changes of office systolic blood pressure at 1-month compared with baseline
Secondary Outcomes
- Ambulatory Blood Pressure(From baseline to 3 months post-procedure)
- Mean Heart Rate(From baseline to 1 month post-procedure)
- Office Systolic Blood Pressure(From baseline to 3 months post-procedure)
- Heart Rate(From baseline to 1 month post-procedure)