Non-invasive Focused Power Ultrasound Mediated Inferior Perirenal Fat Ablation for Lowering Serum Cholesterol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Visceral Obesity
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Xiangqing Kong
Head of Cardiology,Director,Clinical Professor,Principal Investigator
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))