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

NCT06283758 | Recruiting DMC

• 1 other identifier: PARADISE HTN-III
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control.

Conditions

Hypertension; Blood Pressure; Cardiovascular Diseases

Keywords

Hypertension; Cardiovascular diseases; Focused ultrasound; Novel method

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Ambulatory Blood Pressure

  From baseline to 3 month post-procedure

• Office Systolic Blood Pressure

  From baseline to 1 month post-procedure

• Office Systolic Blood Pressure

  From baseline to 3 month post-procedure

• Ambulatory Blood Pressure

  From baseline to 1 month post-procedure

• Ambulatory Blood Pressure

  From baseline to 3 month post-procedure

Other Outcomes (1)

• Incidence of adverse events

  From baseline to 3 month post-procedure

Study Arms (3)

Stage 1: Intervention group

EXPERIMENTAL

This arm is combined with 3 groups and a total of 30 participants will be 1:1:1 allocated (each group with 10 participants). Single treatment group: receive treatment once after enrollment; Consecutive treatment group A: receive 3 consecutive treatments, each with an interval of 3 days; Consecutive treatment group B: receive 3 consecutive treatments, each with an interval of 7 days. In Stage 1, the investigators will select optimal treatment strategy and proceed to Stage 2.

Device: focused power ultrasound mediate inferior perirenal adipose tissue modification

Stage 2: Intervention group

ACTIVE COMPARATOR

Participants will receive optimal treatment strategy selected formerly in Stage 1

Device: focused power ultrasound mediate inferior perirenal adipose tissue modification

Stage 2: 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

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.

Stage 2: Sham-control group

focused power ultrasound mediate inferior perirenal adipose tissue 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.

Stage 1: Intervention group; Stage 2: Intervention 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 with office systolic blood pressure (SBP) ≥ 140 mmHg and \<160 mmHg, and office diastolic blood pressure (DBP)\<100mmHg after standardized antihypertensive drug treatment for 1 month;
• Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥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.

You may not qualify if:

• 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;
• riser hypertension (defined as night blood pressure higher than daytime blood pressure by ABPM)
• Regular night shift workers
• 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;

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead
• The Affiliated Jiangning Hospital of Nanjing Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Affiliated Hospital of Nantong University: collaborator

Study Sites (4)

The Affiliated Jiangning Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

The first Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 210000, China

RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, 210000, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 16355012 BACKGROUND

• 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.

  PMID: 35668093 BACKGROUND

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Central Study Contacts

Yanhui Sheng

CONTACT

13851647530; yhsheng@njmu.edu.cn

Yang Hua

CONTACT

13851624359; 759150674@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Cardiovascular medicine

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)