Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Drug Naive Randomized Controlled Trial (PARADISE-HTN-II)

This randomized, 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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Blood Pressure
• Intervention / Treatment: Device: sham-control group; Device: focused power ultrasound mediate inferior perirenal adipose tissue modification

Detailed Description

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 adipose tissue fibrosis and control the blood pressure in the model of swine. Moreover, the investigators 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, the investigators aim to further evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China
      • The First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210000
      • The Affiliated Jiangning Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China, 215000
      • Suzhou Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and <160 mmHg, and diastolic blood pressure<100mmHg when not taking antihypertensive drugs for at least 1 month;
2. Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥130 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 with office systolic blood pressure (SBP) ≥ 160 mmHg and/or office diastolic blood pressure(DBP)≥ 100mmHg;
2. Individual 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)；
3. Individuals with ≥ 3 cardiovascular risk factors (male>55 years old, female>65 years old; smoking or passive smoking; 2-hour postprandial blood glucose 7.8-11mmol/L and/or impaired fasting glucose (6.1-6.9mmol/L); LDL-C ≥ 3.4mmol/L (130mg/dl), HDL-C<1.0mmol/L (40mg/dl) or TC ≥ 5.2mmol/L (200mg/dl); Family history of early onset of cardiovascular disease, age of onset of first degree relatives<50 years old; Abdominal obesity, waist circumference: male≥90cm, female≥85cm or BMI≥28kg/m2) or hypertensive target organ damage;
4. Individuals taking other medications that may affect blood pressure (such as glucocorticoids);
5. Individual with history of kidney or kidney surrounding tissue surgery;
6. Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference);
7. Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
8. Individual with type 1 diabetes or uncontrolled type 2 diabetes；
9. Individual with uncontrolled thyroid dysfunction;
10. Individual with urinary calculi or hematuria；
11. Individual with atrial fibrillation;
12. Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease);
13. Individual with second degree and above atrioventricular block and/or sick sinus syndrome;
14. Individual with abnormal coagulation function;
15. Individual with infected waist skin;
16. Individual with malignant tumor;
17. Individual is pregnant, nursing or planning to be pregnant;
18. Individual is unwilling to sign informed consent;
19. Individual fails to complete the screening period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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. Intervention: Device: sham-control group	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.
Experimental: 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) Intervention: Device: focused power ultrasound mediate inferior perirenal adipose tissue modification	Device: focused power ultrasound mediate inferior perirenal adipose tissue 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory Blood Pressure	Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline	From baseline to 1 month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office Systolic Blood Pressure	Changes of office systolic blood pressure at 1-month compared with baseline	From baseline to 1 month post-procedure
Ambulatory Blood Pressure	Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline	From baseline to 3 month post-procedure
Office Systolic Blood Pressure	Changes of office systolic blood pressure at 3-month compared with baseline	From baseline to 3 month post-procedure
Ambulatory Blood Pressure	Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline	From baseline to 1 month post-procedure
Ambulatory Blood Pressure	Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline	From baseline to 3 month post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Any severe adverse events (SAE) related to intervention. The SAE were defined as acute renal failure, acute intestinal perforation, and thromboembolic events, et al.	From baseline to 3 month post-procedure

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Suzhou Municipal Hospital; The First People's Hospital of Changzhou; The Affiliated Jiangning Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• Hutley L, Prins JB. Fat as an endocrine organ: relationship to the metabolic syndrome. Am J Med Sci. 2005 Dec;330(6):280-9. doi: 10.1097/00000441-200512000-00005.
• Li P, Liu B, Wu X, Lu Y, Qiu M, Shen Y, Tian Y, Liu C, Chen X, Yang C, Deng M, Wang Y, Gu J, Su Z, Chen X, Zhao K, Sheng Y, Zhang S, Sun W, Kong X. Perirenal adipose afferent nerves sustain pathological high blood pressure in rats. Nat Commun. 2022 Jun 6;13(1):3130. doi: 10.1038/s41467-022-30868-6.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): April 20, 2025

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Hypertension; Focused ultrasound; Novel method
• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: PARADISE-HTN-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No