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

NCT05049096 | Terminated DMC

• 1 other identifier: PARADISE-HTN
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypertension; Blood Pressure; Cardiovascular Diseases

Keywords

Hypertension; Cardiovascular disease; Focused ultrasound; Novel method

Outcome Measures

Primary Outcomes (1)

• Office Systolic Blood Pressure

  Changes of office systolic blood pressure at 1-month compared with baseline

  From baseline to 1 month post-procedure

Secondary Outcomes (5)

• Office Systolic Blood Pressure

  From baseline to 3 months post-procedure

• Ambulatory Blood Pressure

  From baseline to 1 month post-procedure

• Ambulatory Blood Pressure

  From baseline to 3 months post-procedure

• Heart Rate

  From baseline to 1 month post-procedure

• Mean Heart Rate

  From baseline to 1 month post-procedure

Other Outcomes (1)

• Safety evaluation

  From baseline to 1 month post-procedure

Study Arms (2)

intervention group

EXPERIMENTAL

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)

Device: focused power ultrasound mediate inferior perirenal adipose tussue modification

sham-control group

SHAM COMPARATOR

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.

Device: sham-control group

Interventions

focused power ultrasound mediate inferior perirenal adipose tussue modification 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.

intervention group

sham-control group 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.

sham-control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 mmHg；
• The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；
• Individual is willing to sign the informed consent of the study.

You may not qualify if:

• 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)；
• Individual has history of kidney and or kidney surrounding tissue surgery;
• Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference);
• Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
• Individual has type 1 diabetes or poorly-controlled type 2 diabetes；
• Individual has uncontrolled thyroid dysfunction;
• Individual has urinary calculi and/or hematuria；
• Individual has atrial fibrillation;
• Individual has severe structural heart disease (e.g. heart valve disease, cardiomyopathy, congenital heart disease);
• Individual has second degree and above atrioventricular block；
• Individual has abnormal coagulation function;
• Individual has infected waist skin;
• Individual has malignant tumor;
• Individual is pregnant, nursing or planning to be pregnant;
• Individual is unwilling to sign informed consent;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (3)

Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

The Affiliated Jiangning Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

Location

Related Publications (5)

• 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.

  PMID: 15197016 RESULT

• 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.

  PMID: 25190234 RESULT

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

  PMID: 6355012 RESULT

• 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.

  PMID: 40487756 DERIVED

• 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.

  PMID: 36959658 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Xiangqing Kong, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: November 1, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)