Non-invasive Focused Power Ultrasound Mediated Inferior Perirenal Fat Ablation for Lowering Serum Cholesterol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The difference in low-density lipoprotein cholesterol (LDL-C) levels between the FPU-treatment and sham treatment groups from baseline to 3 months post-procedure
研究概览
简要总结
The goal of this clinical trial is to learn about focused power ultrasound (FPU)-mediated perirenal fat (PRF) ablation for lowering serum cholesterol levels. The main questions it aims to answer are:
What is the efficacy, safety, and tolerability of focused power ultrasound (FPU)-mediated perirenal fat ablation for lowering low-density lipoprotein cholesterol (LDL-C) levels? Participants will randomly receive PRF ablation or sham treatment, and undergo follow-up at 24 hours, 1 month, and 3 months post-procedure.
详细描述
This study aims to evaluate and validate the efficacy and safety of the therapeutic approach of PRF ablation-executed by an externally delivered, completely non-invasive FPU-on serum cholesterol levels in patients with dyslipidaemia, with a low-to-moderate 10-year overall risk of ASCVD.
This is an investigator-initiated, single site, randomised, double-blinded, sham-controlled clinical trial. Further eligibility assessment will be performed at the secondary screening, which has the same design as the baseline examination. Subjects taking lipid-lowering drugs before the recruitment are permitted to enter the secondary screening after a 4-week washout period, to allow for sufficient elimination. Eighty-four eligible participants will be randomly assigned to either the FPU treatment group or the sham-treatment group, at a ratio of 2:1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged 18-70 years old.
- •Each side of caudal perirenal fat volume >8000mm3（measured by ultrasound).
- •Low and medium-risk of arteriosclerotic cardiovascular disease (ASCVD) with 3.4 ≤ LDL-C < 4.9 mmol/L or 5.2 ≤ TC < 7.2 mmol/L, as defined by the Chinese guidelines for the management of dyslipidemia in adults(revised edition 2016).
- •Participants should be willing to sign the informed consent form of the study.
排除标准
- •Familial hyperlipidemia.
- •Participants are taking cholesterol metabolism related drugs (e.g. fibrate drugs, thiazide diuretics, glucocorticoid, para-amino salicylic acid, colchicine, thyroid hormone, thyroid preparation, hypoglycemic, heparin, new oral anticoagulant, chlortetracycline, kanamycin, neomycin).
- •Participants are unwilling to stop taking statins.
- •Presence of history of hypertension and at least 2 of the following risk factors:
- •History of smoking (more than 10 years and more than 10 cigarettes per day).
- •Male ≥ 45 years old, female ≥ 55 years old.
- •HDL-C≤1 mmol/L.
- •Presence of clinical documented atherosclerotic cardiovascular diseases (including acute coronary syndrome, stable angina, coronary revascularization, ischemic cardiomyopathy, stroke, transient cerebral ischemia and peripheral atherosclerosis disease defined as stenosis ≥50% or complex plaques of lower limb arteries, renal arteries, carotid arteries and other peripheral arteries).
- •Presence of cardiovascular diseases(e.g. all types of atrial fibrillation; severe structural heart disease including severe pulmonary hypertension resulting from severe aortic or ventricular septal defect, complicated anomaly and severe valvular disease; second degree or above heart block).
- •Presence of previous surgery of kidney or pararenal tissue.
- •Presence of endocrine-related diseases(e.g. Diabetes, Cushing syndrome, thyroidectomy or thyroid dysfunction in need of drug treatment, primary aldosteronism, Hypofunction of adrenal cortex, Polycystic Ovary Syndrome, Hyperparathyroidism, Insulin tumor, Zollinger-Ellison syndrome).
- •Presence of autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, Sjögren syndrome, scleroderma, ulcerative colitis, dermatomyositis, pemphigus, mixed connective tissue disease, sarcoidosis, Takayasu Arteritis).
- •Presence of severe hematologic diseases (e.g. leukemia, lymphoma, aplastic anemia, autoimmune hemolytic anemia, multiple myeloma, Primary Immune Thrombocytopenia, thrombotic thrombocytopenic Purpura, abnormal coagulation).
- •Presence of infectious diseases (e.g. Hepatitis, tuberculosis, AIDS, syphilis, malaria, measles).
- •Presence of parasitic diseases.
- •Presence of significant liver dysfunction (ALT or AST elevation greater than 2 times normal upper limit or other evidence of liver injury).
- •Presence of significant renal dysfunction (GFR< 90 mL / min / 1.73 m2 or other evidence of renal injury).
- •Presence of urinary calculi and/or hematuria (gross hematuria or occult blood positive).
- •Presence of skin infection at the waist.
- •Presence of active malignancy.
- •Pregnant women or in suckling period or planning for pregnancy in trial period.
- •Participants are unwilling to sign an informed consent form.
- •Participants are unable or unwilling to complete follow-up evaluations.
结局指标
主要结局
The difference in low-density lipoprotein cholesterol (LDL-C) levels between the FPU-treatment and sham treatment groups from baseline to 3 months post-procedure
时间窗: Day 0 (baseline) to 3-month (end of follow-up)
The difference in LDL-C levels between the FPU-treatment and sham treatment groups from baseline to 3 months post-procedure.
Incidence of all-cause deaths and serious adverse events
时间窗: Day 0 (baseline) to 3-month (end of follow-up)
Serious adverse events including acute liver failure, acute renal failure, acute intestinal perforation, severe embolic events and etc.
次要结局
- The differences between the groups in blood lipid profiles (total cholesterol(TC), triglycerides(TG), and high-density lipoprotein cholesterol(HDL-C)) from baseline to 3 months post-procedure.(Day 0 (baseline) to 3-month (end of follow-up))
- Incidence of other adverse events(Day 0 (baseline) to 3-month (end of follow-up))
研究者
Xiangqing Kong
Head of Cardiology,Director,Clinical Professor,Principal Investigator
The First Affiliated Hospital with Nanjing Medical University