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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Patients will be placed in the lateral decubitus position and receive treatment with sequential bilateral PRF ablation. Before the treatment, a professional sonographer will be responsible for the length, thickness, and width of PRF sac measurement and localisation, and utilise the ultrasonic diagnostic transducer to delineate the targeted region. The treatment will launch layer-by-layer. After confirming accurate localization of the treatment, layer-by-layer PRF ablation will be performed on the patients. The device generates and delivers a pattern of conic-shaped ultrasound energy to the PRF sac noninvasively. The treatment of FPU-mediated PRF ablation will be implemented once.
Participants will receive the same procedure as those in the FPU treatment including PRF ultrasonic measurement and localization and focused ultrasound treatment parameters setting, except that no energy will be delivered to the PRF.
JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
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
The difference in LDL-C levels between the FPU-treatment and sham treatment groups from baseline to 3 months post-procedure.
Time frame: Day 0 (baseline) to 3-month (end of follow-up)
Incidence of all-cause deaths and serious adverse events
Serious adverse events including acute liver failure, acute renal failure, acute intestinal perforation, severe embolic events and etc.
Time frame: Day 0 (baseline) to 3-month (end of follow-up)
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.
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.
Time frame: Day 0 (baseline) to 3-month (end of follow-up)
Incidence of other adverse events
Other adverse events including liver dysfunction, renal dysfunction, etc. at 3 months post-procedure. The following are the safety assessments: 1. General physical examination and vital signs. 2. Routine blood and urine tests: C-reactive protein (CRP), ALT, AST, urea nitrogen (BUN), creatinine (Cr), and glycosylated haemoglobin (HbAlc). 3. Image examinations: electrocardiogram (ECG), renal and renal artery ultrasound, and mid-abdomen routine computed tomography (MAR-CT). 4. AEs (including ALT or AST ≥ 3 times the upper limit of normal, Cr ≥ 1.5 times the upper limit of normal, and other AEs).
Time frame: Day 0 (baseline) to 3-month (end of follow-up)
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