CONCISE: A Cholesterol Lowering Therapy of Non-invasive High-intensity Focused Ultrasound Mediated Perirenal Fat Modification
Study Details
Study Description
Brief Summary
The research objective is to demonstrate safety and efficacy of perirenal fat modification in the treatment of hypercholesterolemia in a double-blinded and randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Enrolled participants were low-and medium-risk ASCVD as defined by the guidelines, accompanied by serum cholesterol abnormality. 84 patients are planned to be enrolled.The admission rate was 2:1 in the treatment group versus control group, including 56 of the treatment group and 28 of the sham-control group.
In treatment group, participants will receive the peri-renal fat modification therapy (PRFM) and in the sham-control group, participants will undergo peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting, except that no energy will be delivered to the peri-renal fat. The follow-up evaluations will be performed at 24h, 1 month and 3 months post-procedure, including demographic data, serum lipid level, renal ultrasound, renal CT scan and renal MRI if it is necessary.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HIFU treatment Transcutaneous non-invasive ultrasound will be administered to the peri-renal fat for one time via a high-intensity focused ultrasound system(HIFU) device. |
Device: High-intensity focused ultrasound
High-intensity focused ultrasound(HIFU) is an externally delivered, completely noninvasive focused therapeutic ultrasound device.It is capable of focusing the resulting ultrasound beam to a small "cigar"-shaped volume,which leads to the rapid elevation of the peri-renal adipose tissue temperature and the modification of target tissue eventually.
|
| Sham Comparator: Sham treatment Partcipates will receive the same procedure as those in experimental arm except that the device will not be activated. |
Device: Sham treatment
Participants will receive the same procedure as those in the HIFU treatment including peri-renal fat ultrasonic measurement and localization and focused ultrasound treatment parameters setting, except that no energy will be delivered to the peri-renal fat.
|
Outcome Measures
Primary Outcome Measures
- Change of serum low-density lipoprotein cholesterol(LDL-C) [Day 0 (baseline) to Day 90 (end of follow-up)]
Within-arm and Between-arm changes in the serum low-density lipoprotein cholesterol(LDL-C) level from baseline to end of 3 month follow-up for treatment group.
- Incidence of all-cause deaths and serious adverse events [Day 0 (baseline) to Day 90 (end of follow-up)]
Serious adverse events including acute liver failure, acute renal failure, acute intestinal perforation, severe embolic events and etc.
Secondary Outcome Measures
- Changs of serum total cholesterol(TC), triglycerides(TG), and high-density lipoprotein cholesterol(HDL-C) [Day 0 (baseline) to Day 90 (end of follow-up)]
Within-arm and Between-arm changes in the total cholesterol(TC), triglycerides(TG), and high-density lipoprotein cholesterol(HDL-C) levels from baseline to end of 3 month follow-up for treatment group.
- Incidence of other adverse events [Day 0 (baseline) to Day 90 (end of follow-up)]
Other adverse events including ALT, AST increased more than 3 times the upper limit of normal, serum creatinine increased more than 1.5 times the baseline level and etc.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | JiangSu Province Hospital / The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
Investigators
- Principal Investigator: Xiangqing Kong, M.D.&PhD, The First Affiliated Hospital with Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-SR-388