Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Double-blinded Controlled Trial. PARADISE Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- Office Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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；
- •Individual has abnormal coagulation function;
- •Individual has infected waist skin;
- •Individual has 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.
结局指标
主要结局
Office Systolic Blood Pressure
时间窗: From baseline to 1 month post-procedure
Changes of office systolic blood pressure at 1-month compared with baseline
次要结局
- 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)