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

Primary Purpose

Hypertension, Blood Pressure, Cardiovascular Diseases

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

focused power ultrasound mediate inferior perirenal adipose tussue modification

sham-control group

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Cardiovascular disease, Focused ultrasound, Novel method

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Individual fails to complete the screening period.

Sites / Locations

Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical UniversityRecruiting
The Affiliated Jiangning Hospital of Nanjing Medical UniversityRecruiting
Suzhou Municipal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

intervention group

sham-control group

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Office Systolic Blood Pressure

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

Secondary Outcome Measures

Office Systolic Blood Pressure

Changes of office blood pressure at 3-month compared with baseline

Ambulatory Blood Pressure

Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline

Ambulatory Blood Pressure

Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline

Heart Rate

Changes of the heart rate at 1-month compared with baseline

Mean Heart Rate

Changes of the mean heart rate measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline

Full Information

NCT ID

NCT05049096

First Posted

September 7, 2021

Last Updated

March 9, 2023

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05049096

Brief Title

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

Acronym

PARADISE-HTN

Official Title

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Double-blinded Controlled Trial. PARADISE Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

July 31, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Blood Pressure, Cardiovascular Diseases

Keywords

Hypertension, Cardiovascular disease, Focused ultrasound, Novel method

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Masking Description

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

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Description

Arm Title

sham-control group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

focused power ultrasound mediate inferior perirenal adipose tussue modification

Intervention Description

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

Intervention Name(s)

sham-control group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Office Systolic Blood Pressure

Description

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

Time Frame

From baseline to 1 month post-procedure

Secondary Outcome Measure Information:

Title

Office Systolic Blood Pressure

Description

Changes of office blood pressure at 3-month compared with baseline

Time Frame

From baseline to 3 months post-procedure

Title

Ambulatory Blood Pressure

Description

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

Title

Ambulatory Blood Pressure

Description

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 months post-procedure

Title

Heart Rate

Description

Changes of the heart rate at 1-month compared with baseline

Time Frame

From baseline to 1 month post-procedure

Title

Mean Heart Rate

Description

Changes of the mean heart rate measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline

Time Frame

From baseline to 1 month post-procedure

Other Pre-specified Outcome Measures:

Title

Safety evaluation

Description

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 1 month post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Individual fails to complete the screening period.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiangqing Kong, MD

Phone

13951610265

kongxq@njmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Sun, MD

Phone

13815860536

shunwee@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiangqing Kong, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiangqing Kong, MD

Phone

13951610265

kongxq@njmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Wei Sun, MD

Phone

13815860536

Shunwee@126.com

Facility Name

The Affiliated Jiangning Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuqing Zhang, MD

Facility Name

Suzhou Municipal Hospital

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanhui Sheng, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15197016

Citation

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.

Results Reference

result

PubMed Identifier

25190234

Citation

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.

Results Reference

result

PubMed Identifier

6355012

Citation

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

Results Reference

result

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

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