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

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 tissue modification
sham-control group
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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 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: 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.

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) Intervention: Device: focused power ultrasound mediate inferior perirenal adipose tissue modification

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ambulatory Blood Pressure
Changes of mean systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline
Office Systolic Blood Pressure
Changes of office systolic blood pressure at 1-month compared with baseline
Office Systolic Blood Pressure
Changes of office systolic blood pressure at 3-month compared with baseline
Ambulatory Blood Pressure
Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 1-month compared with baseline
Ambulatory Blood Pressure
Changes of mean diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring at 3-month compared with baseline
Home Blood Pressure
Changes of home blood pressure at 1-month compared with baseline
Home Blood Pressure
Changes of home blood pressure at 3-month compared with baseline

Full Information

First Posted
August 25, 2023
Last Updated
September 21, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
The Affiliated Jiangning Hospital of Nanjing Medical University, Suzhou Municipal Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06018493
Brief Title
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)
Official Title
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Drug Naive Randomized Controlled Trial (PARADISE-HTN-II)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
The Affiliated Jiangning Hospital of Nanjing Medical University, Suzhou Municipal Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

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 randomized, 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
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
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) Intervention: Device: focused power ultrasound mediate inferior perirenal adipose tissue modification
Arm Title
sham-control group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
focused power ultrasound mediate inferior perirenal adipose tissue 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
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
Secondary Outcome Measure Information:
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 month post-procedure
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
Title
Office Systolic Blood Pressure
Description
Changes of office systolic blood pressure at 3-month compared with baseline
Time Frame
From baseline to 3 month post-procedure
Title
Ambulatory Blood Pressure
Description
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
Title
Ambulatory Blood Pressure
Description
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
Title
Home Blood Pressure
Description
Changes of home blood pressure at 1-month compared with baseline
Time Frame
From baseline to 1 months post-procedure
Title
Home Blood Pressure
Description
Changes of home blood pressure at 3-month compared with baseline
Time Frame
From baseline to 3 months 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 3 month post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangqing Kong
Phone
13951610265
Email
kongxq@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Sun
Phone
13815860536
Email
shunwee@126.com
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
Email
kongxq@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wei Sun, MD
Phone
13815860536
Email
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
No
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
background
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
background
PubMed Identifier
16355012
Citation
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.
Results Reference
background
PubMed Identifier
35668093
Citation
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.
Results Reference
background

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

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