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New treatment option for Hypertension
Official title Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)
ClinicalTrials.gov ID: NCT06283758
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and \<160 mmHg, and office diastolic blood pressure (DBP)\<100mmHg after standardized...
- 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 likely can't join if
- Individual diagnosed as secondary hypertension (e.g. renal parenchymal hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma...
- Individuals with ≥ 3 cardiovascular risk factors (male\>55 years old, female\>65 years old; smoking or passive smoking; 2-hour postprandial blood...
- 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;
See the full eligibility criteria
- 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.
- Individual diagnosed as secondary hypertension (e.g. renal parenchymal hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, aortic coarctation, obstructive sleep apnea...
- 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)...
- 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;
- Individual with infected waist skin;
- Individual with claustrophobia；
- Individual with malignant tumor;
- History of allergy to amlodipine, olmesartan, and hydrochlorothiazide
- Individual is pregnant, nursing or planning to be pregnant;
- Individual is unwilling to sign informed consent;
- Individual fails to complete the screening period.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Nantong, Jiangsu, China; Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.