search
Back to results

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

Primary Purpose

Visceral Obesity, Ultrasound Therapy, Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
focused power ultrasound treatment
Sham treatment
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visceral Obesity focused on measuring Perirenal fat, Ultrasound Therapy, Dyslipidemias, low-density lipoprotein cholesterol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.
  8. 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).
  9. 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).
  10. Presence of severe hematologic diseases (e.g. leukemia, lymphoma, aplastic anemia, autoimmune hemolytic anemia, multiple myeloma, Primary Immune Thrombocytopenia, thrombotic thrombocytopenic Purpura, abnormal coagulation).
  11. Presence of infectious diseases (e.g. Hepatitis, tuberculosis, AIDS, syphilis, malaria, measles).
  12. Presence of parasitic diseases.
  13. Presence of significant liver dysfunction (ALT or AST elevation greater than 2 times normal upper limit or other evidence of liver injury).
  14. Presence of significant renal dysfunction (GFR< 90 mL / min / 1.73 m2 or other evidence of renal injury).
  15. Presence of urinary calculi and/or hematuria (gross hematuria or occult blood positive).
  16. Presence of skin infection at the waist.
  17. Presence of active malignancy.
  18. Pregnant women or in suckling period or planning for pregnancy in trial period.
  19. Participants are unwilling to sign an informed consent form.
  20. Participants are unable or unwilling to complete follow-up evaluations.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

FPU treatment

Sham treatment

Arm Description

Transcutaneous non-invasive ultrasound will be administered to the peri-renal fat for one time via a focused power ultrasound system (FPU) device.

Partcipates will receive the same procedure as those in experimental arm except that the device will not be activated.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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: General physical examination and vital signs. Routine blood and urine tests: C-reactive protein (CRP), ALT, AST, urea nitrogen (BUN), creatinine (Cr), and glycosylated haemoglobin (HbAlc). Image examinations: electrocardiogram (ECG), renal and renal artery ultrasound, and mid-abdomen routine computed tomography (MAR-CT). AEs (including ALT or AST ≥ 3 times the upper limit of normal, Cr ≥ 1.5 times the upper limit of normal, and other AEs).

Full Information

First Posted
January 6, 2020
Last Updated
July 4, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04223557
Brief Title
A Cholesterol Lowering Therapy of Focused Power Ultrasound Mediated Perirenal Fat Ablation
Acronym
CONCISE
Official Title
Non-invasive Focused Power Ultrasound Mediated Inferior Perirenal Fat Ablation for Lowering Serum Cholesterol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Obesity, Ultrasound Therapy, Dyslipidemias
Keywords
Perirenal fat, Ultrasound Therapy, Dyslipidemias, low-density lipoprotein cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, double-blinded, sham-controlled study.The ratio of the treatment group versus sham-control group was 2:1.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FPU treatment
Arm Type
Experimental
Arm Description
Transcutaneous non-invasive ultrasound will be administered to the peri-renal fat for one time via a focused power ultrasound system (FPU) device.
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Partcipates will receive the same procedure as those in experimental arm except that the device will not be activated.
Intervention Type
Device
Intervention Name(s)
focused power ultrasound treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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)
Title
Incidence of all-cause deaths and serious adverse events
Description
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)
Secondary Outcome Measure Information:
Title
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.
Description
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)
Title
Incidence of other adverse events
Description
Other adverse events including liver dysfunction, renal dysfunction, etc. at 3 months post-procedure. The following are the safety assessments: General physical examination and vital signs. Routine blood and urine tests: C-reactive protein (CRP), ALT, AST, urea nitrogen (BUN), creatinine (Cr), and glycosylated haemoglobin (HbAlc). Image examinations: electrocardiogram (ECG), renal and renal artery ultrasound, and mid-abdomen routine computed tomography (MAR-CT). 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangqing Kong, M.D.&PhD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs