MedDataX Logo

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension

NCT ID: NCT05049096

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized, double blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The increase of visceral fat is closely related to the occurrence of hypertension, and it is one of the main independent risk factors of hypertension. Visceral fat has been recognized as an important endocrine organ, and a variety of factors secreted by visceral fat lead to an increased risk of cardiovascular disease. Peri-renal fat is a special type of visceral fat which is different from other type of visceral fat in histology, physiology, and functions. The positon of peri-renal fat is more stable than other visceral fat, which might be influenced by breath or body position changes.Studies have found that perirenal fat is an early predictor of ASCVD, and its accumulation is closely related to the occurrence and development of ASCVD.Therefore, the reduction or modification of visceral fat,especially peri-renal fat , has a sufficient scientific basis for the treatment of hypertension.

In our previous experiments, this novel focused power ultrasound can rapidly and efficiently promote the perirenal adipse tissue fibrosis and control the blood pressure in the model of swine. Moreover, we performed a single arm, small sample study to investigate the feasibility of the novel focused power ultrasound to modify the inferior perirenal adipose tissue in human volunteers, showing that this kind of method was feasible and safe.

In this study, we aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Blood Pressure Cardiovascular Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hypertension Cardiovascular disease Focused ultrasound Novel method

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a ramdomized, double-blinded, and sham-control study. The ratio of the intervention group versus sham-control group is 1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The masking range includes participants, most researchers (including the study leader; subjects screening researchers; follow-up researchers; sonographers; MR scanners, members of the clinical endpoint identification committee,and etc.) except for the study statistical analysts and the therapy operators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

In intervention group, participants will receive the whole peri-renal fat modification therapy (including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting and initiating)

Group Type EXPERIMENTAL

focused power ultrasound mediate inferior perirenal adipose tussue modification

Intervention Type DEVICE

This novel focused power ultrasound 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 and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.

sham-control group

In sham control group, participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.

Group Type SHAM_COMPARATOR

sham-control group

Intervention Type DEVICE

participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

focused power ultrasound mediate inferior perirenal adipose tussue modification

This novel focused power ultrasound 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 and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually.

Intervention Type DEVICE

sham-control group

participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Individual has office systolic blood pressure (SBP) ≥ 140 mmHg and \<180 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes；
2. Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 mmHg；
3. The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；
4. Individual is willing to sign the informed consent of the study.

Exclusion Criteria

1. Individual is diagnosed as secondary hypertension (e.g. renal parenchymal hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, aortic coarctation, obstructive sleep apnea hypopnea syndrome)；
2. Individual has history of kidney and or kidney surrounding tissue surgery;
3. Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference);
4. Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
5. Individual has type 1 diabetes or poorly-controlled type 2 diabetes；
6. Individual has uncontrolled thyroid dysfunction;
7. Individual has urinary calculi and/or hematuria；
8. Individual has atrial fibrillation;
9. Individual has severe structural heart disease (e.g. heart valve disease, cardiomyopathy, congenital heart disease);
10. Individual has second degree and above atrioventricular block；
11. Individual has abnormal coagulation function;
12. Individual has infected waist skin;
13. Individual has malignant tumor;
14. Individual is pregnant, nursing or planning to be pregnant;
15. Individual is unwilling to sign informed consent;
16. Individual fails to complete the screening period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiangqing Kong, MD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu province Hospital/The First Affiliated Hospital of Nanjing Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

The Affiliated Jiangning Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Hayashi T, Boyko EJ, Leonetti DL, McNeely MJ, Newell-Morris L, Kahn SE, Fujimoto WY. Visceral adiposity is an independent predictor of incident hypertension in Japanese Americans. Ann Intern Med. 2004 Jun 15;140(12):992-1000. doi: 10.7326/0003-4819-140-12-200406150-00008.

Reference Type RESULT
PMID: 15197016 (View on PubMed)

Chandra A, Neeland IJ, Berry JD, Ayers CR, Rohatgi A, Das SR, Khera A, McGuire DK, de Lemos JA, Turer AT. The relationship of body mass and fat distribution with incident hypertension: observations from the Dallas Heart Study. J Am Coll Cardiol. 2014 Sep 9;64(10):997-1002. doi: 10.1016/j.jacc.2014.05.057.

Reference Type RESULT
PMID: 25190234 (View on PubMed)

Djawari D, Haneke E. [Therapy of recurrent oral aphthae with thymopoetin pentapeptide]. Hautarzt. 1983 Sep;34(9):463-4. German.

Reference Type RESULT
PMID: 6355012 (View on PubMed)

Hua Y, Li MH, Lou YX, Zhang KR, Yang JM, Sheng YH, Zhang YQ, Cheng CL, Zou C, Wu TT, Kong XQ, Sun W. Perirenal fat as a potential marker and therapeutic target for metabolic syndrome: insights from a multicenter randomized controlled trial. Front Endocrinol (Lausanne). 2025 May 23;16:1557701. doi: 10.3389/fendo.2025.1557701. eCollection 2025.

Reference Type DERIVED
PMID: 40487756 (View on PubMed)

Li M, Shi J, Sheng Y, Zhang Y, Wu T, Yang J, Zhang K, Sun W, Kong X. Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study. Trials. 2023 Mar 23;24(1):221. doi: 10.1186/s13063-023-07249-5.

Reference Type DERIVED
PMID: 36959658 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PARADISE-HTN

Identifier Type: -

Identifier Source: org_study_id