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Clinical Trials in China / NCT07232966
Starting soon Phase 3

Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension

NCT07232966 · tracked via the Priya Life Science China tracker
Sponsor
Yan Li
Phase
Phase 3
Started
2025-11-20
Last updated
2025-11-18

Condition(s) studied

Resistant Hypertension

Investigational drug(s) / intervention(s)

Perirenal adipose tissue modification by focused power ultrasoundSham

Perirenal adipose tissue modification by focused power ultrasound: Perirenal adipose tissue modification by focused power ultrasound at both kidneys

Sham: Sham procedure of focused ultrasound at both kidneys

Study summary

The goal of this clinical trial is to investigate if focused power ultrasound (FPU) targeted perirenal adipose tissue modification therapy would be effective and safe in treating resistant hypertension. The primary outcome of the study is the difference in the reduction of 24h mean systolic blood pressure between treatment and sham procedure groups 6 months after treatment. The secondary outcomes include the reduction of clinic blood pressure 1, 3, and 6 months after treatment, the reduction of 24h mean blood pressure 1, 3, and 6 months after treatment, and the drug burden of antihypertensive treatment. The safety evaluation includes the incidence of all-cause death, cardiovascular events (stroke and myocardial infarction), renal failure, and other adverse events.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female participants aged 18-75 years old; 2. 24h ambulatory systolic BP ≥130mmHg and \<150mmHg, and 24h ambulatory diastolic BP \<100mmHg after at least 4 weeks of combined treatment with 3 antihypertensive drugs (including a diuretic); 3. The ultrasound measured inferior perirenal adipose tissue ≥8 cm3 (with the superior-inferior diameter, left-right diameter, and anterior-posterior diameter all needing to be ≥20 mm); 4. Be willing to participate in the trial, and be able to visit doctors by himself or herself; 5. Sign the informed consent form. Exclusion Criteria: 1. Secondary hypertension; 2. Occurrence of myocardial infarction, malignant arrhythmia, severe renal failure, or stroke within 6 months; 3. Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings); 4. Alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin (TBL) above twice the normal range; eGFR (CKD-EPI) \<45mL/min/1.73m2; 5. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (glycated hemoglobin ≥8.5%); 6. Single functionally normal kidney or presence of renal malignant tumor; 7. Bilateral skin diseases at renal region that are not suitable for the therapy; 8. Women in pregnancy, lactating, or planning for pregnancy; 9. Other concomitant diseases that are considered not suitable for participation in the trial; 10. Patients have contraindications to angiotensin receptor-neprilysin inhibitor (ARNIs), thiazide-like diuretic drugs, or calcium channel blocker (CCBs); 11. Non-compliant patients.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07232966 on ClinicalTrials.gov ↗ ← All trials in China