NCT07232966

Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension

The Efficacy and Safety of Perirenal Adipose Tissue Modification Therapy by Focused Power Ultrasound for Resistant Hypertension

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Yan Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypertension is the most common cardiovascular disease. However, the control rate of hypertension in China is very low. Resistant hypertension is defined as uncontrolled blood pressure despite optimal lifestyle modifications and the use of three appropriately tolerated, maximally dosed antihypertensive drugs (including a diuretic), or controlled blood pressure with four antihypertensive drugs. Resistant hypertension is associated with increased cardiovascular risk and poor prognosis. Previous studies have shown that bilateral perirenal adipose tissue (PRAT) ablation or denervation leads to a long-term blood pressure reduction in spontaneous hypertensive rats. Focused power ultrasound (FPU) targeted PRAT modification therapy is a novel intervention aiming to physically or chemically modify PRAT using ultrasound energy, remove nerve fibers, and treat hypertension. Preliminary feasibility and safety was proved in a pilot study of 20 patients. However, a larger, randomized trial is needed to prove efficacy and long-term safety of the treatment. Participants with resistant hypertension will be recruited in 10 centers and then to investigate whether PRAT modification therapy by FPU is effective and safe for patients with resistant hypertension.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
PROCEDURE	Perirenal adipose tissue modification by focused power ultrasound	Perirenal adipose tissue modification by focused power ultrasound at both kidneys
PROCEDURE	Sham	Sham procedure of focused ultrasound at both kidneys

Timeline

• Start date: 2025-11-20
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China