Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Esse… (NCT06018493) | Clinical Trial Compass
CompletedNot Applicable
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)
China79 participantsStarted 2023-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ambulatory Blood Pressure
Timeframe: From baseline to 1 month post-procedure
Trial details
NCT IDNCT06018493
SponsorThe First Affiliated Hospital with Nanjing Medical University
. 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；