A Cholesterol Lowering Therapy of Focused Power Ultrasound Mediated Perirenal Fat Ablation

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.