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

Non-invasive Focused Power Ultrasound Mediated Inferior Perirenal Fat Ablation for Lowering Serum Cholesterol

NCT04223557•The First Affiliated Hospital with Nanjing Medical University

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and Females aged 18-70 years old.
•2. Each side of caudal perirenal fat volume \>8000mm3（measured by ultrasound).
•3. 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).
•4. Participants should be willing to sign the informed consent form of the study.

Exclusion Criteria

•1. Familial hyperlipidemia.
•2. 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).
•3. Participants are unwilling to stop taking statins.
•4. 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.
•5. 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).
•6. 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).
•7. Presence of previous surgery of kidney or pararenal tissue.
+13 more criteria

Locations (1)

JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

May 30, 2020

Primary Completion Date

July 8, 2021

Completion Date

December 31, 2021

Last Updated

July 6, 2023

Enrollment

ACTUAL participants

Conditions

Visceral ObesityUltrasound TherapyDyslipidemias

Interventions

focused power ultrasound treatment

DEVICE

Sham treatment

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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