Clinical trial NCT05049096: Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension
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
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Blood Pressure
Cardiovascular Diseases
Keywords: Hypertension
Cardiovascular disease
Focused ultrasound
Novel method
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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；
2. Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥135 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 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)；
2. Individual has history of kidney and or kidney surrounding tissue surgery;
3. Individuals has impairment of liver or kidney function (ALT, AST or creatinine is greater than 2 times of the upper limit of normal reference);
4. Individual has myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack within 6 months of enrollment;
5. Individual has type 1 diabetes or poorly-controlled type 2 diabetes；
6. Individual has uncontrolled thyroid dysfunction;
7. Individual has urinary calculi and/or hematuria；
8. Individual has atrial fibrillation;
9. Individual has severe structural heart disease (e.g. heart valve disease, cardiomyopathy, congenital heart disease);
10. Individual has second degree and above atrioventricular block；
11. Individual has abnormal coagulation function;
12. Individual has infected waist skin;
13. Individual has malignant tumor;
14. Individual is pregnant, nursing or planning to be pregnant;
15. Individual is unwilling to sign informed consent;
16. Individual fails to complete the screening period.

Primary outcomes:
measure: Office Systolic Blood Pressure
timeFrame: From baseline to 1 month post-procedure
Secondary outcomes:
measure: Office Systolic Blood Pressure
timeFrame: From baseline to 3 months post-procedure
measure: Ambulatory Blood Pressure
timeFrame: From baseline to 1 month post-procedure
measure: Ambulatory Blood Pressure
timeFrame: From baseline to 3 months post-procedure
measure: Heart Rate
timeFrame: From baseline to 1 month post-procedure
measure: Mean Heart Rate
timeFrame: From baseline to 1 month post-procedure
Other outcomes:
measure: Safety evaluation
timeFrame: From baseline to 1 month post-procedure
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital/The Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Affiliated Jiangning Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu province Hospital/The First Affiliated Hospital of Nanjing Medical University
name: Xiangqing Kong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Djawari D, Haneke E. [Therapy of recurrent oral aphthae with thymopoetin pentapeptide]. Hautarzt. 1983 Sep;34(9):463-4. German.