Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Esse… (NCT06283758) | Clinical Trial Compass
RecruitingNot Applicable
Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III)
China30 participantsStarted 2024-03-01
Plain-language summary
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. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion 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.
✕. 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;
What they're measuring
1
Ambulatory Blood Pressure
Timeframe: From baseline to 1 month post-procedure
✕. 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;