CompletedNCT06018493Updated Feb 27, 2026

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

An interventional study of focused power ultrasound mediate inferior perirenal adipose tissue modification and sham-control group in Hypertension, Blood Pressure and Cardiovascular Diseases, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 4 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 79
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Read the 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.

Conditions studied

Hypertension
Blood Pressure
Cardiovascular Diseases

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Keywords

Hypertension
Cardiovascular disease
Focused ultrasound
Novel method

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 79 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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;
Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥130 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.

Exclusion criteria

Exclusion Criteria:

Individual with office systolic blood pressure (SBP) ≥ 160 mmHg and/or office diastolic blood pressure(DBP)≥ 100mmHg;
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)；
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;
Individuals taking other medications that may affect blood pressure (such as glucocorticoids);
Individual with history of kidney or kidney surrounding tissue surgery;
Individuals with impairment of liver or kidney function (ALT, AST or creatinine greater than 2 times of the upper limit of normal reference);
Individual with myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
Individual with type 1 diabetes or uncontrolled type 2 diabetes；
Individual with uncontrolled thyroid dysfunction;
Individual with urinary calculi or hematuria；
Individual with atrial fibrillation;
Individual with severe structural heart disease (e.g. valvular heart disease, cardiomyopathy, congenital heart disease);
Individual with second degree and above atrioventricular block and/or sick sinus syndrome;
Individual with abnormal coagulation function;
Individual with infected waist skin;
Individual with malignant tumor;
Individual is pregnant, nursing or planning to be pregnant;
Individual is unwilling to sign informed consent;
Individual fails to complete the screening period.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 79 participants (actual)

Study arms

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
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

Interventions

Devicefocused 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.
Devicesham-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.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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.
Time frame: From baseline to 3 month post-procedure

Study locations

4 sites

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

References and documents

Publications

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. PubMed 15197016 ↗
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. PubMed 25190234 ↗
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. PubMed 16355012 ↗
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. PubMed 35668093 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06018493
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Collaborators: The Affiliated Jiangning Hospital of Nanjing Medical University, Suzhou Municipal Hospital, The First People's Hospital of Changzhou
Responsible party: Xiangqing Kong (Head of Cardiology, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted: Aug 30, 2023
Start date: Sep 1, 2023
Primary completion: Feb 12, 2025
Completion: Apr 20, 2025
Last update: Feb 27, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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