Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension

NCT07232966 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025148
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resistant Hypertension

Keywords

perirenal adipose tissue; focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Reduction in 24h systolic blood pressure at the 6-month after treatment

  6 months after treatment

Secondary Outcomes (7)

• Reduction in 24h ambulatory systolic/diastolic blood pressure

  1 month after treatment

• Reductions in 24h ambulatory systolic/diastolic blood pressure

  3 months after treatment

• Reduction in 24h ambulatory diastolic blood pressure

  6 months after treatment

• Reduction in clinic systolic/diastolic blood pressure

  1 month after treatment

• Reduction in clinic systolic/diastolic blood pressure

  3 months after treatment

Other Outcomes (3)

• The incidence rate of all-cause death

  6 months after treatment

• The incidence of cardiovascular events

  6 months after treatment

• The incidence of renal failure

  6 months after treatment

Study Arms (2)

Perirenal adipose tissue modification by focused power ultrasound

EXPERIMENTAL

Perirenal adipose tissue modification (PRATM) by focused power ultrasound at both kidneys will be performed after the randomisation of eligible patients. After 1 month, if 24-h BP was uncontrolled and of at least 145/100 mmHg, alisartan /indapamide 240/1.5mg once daily will be replaced by sacubitril alisartan 232/248mg and indapamide 1.5mg once daily. At the 3-month after the treatment, if BP was uncontrolled, amlodipine will be uptitrated to 5mg twice a day. The duration of the follow-up after randomisation will be 6 months.

Procedure: Perirenal adipose tissue modification by focused power ultrasound

Sham

SHAM COMPARATOR

Sham procedure will be performed at both kidneys after the randomisation of eligible patients. After 1 month, if 24-h BP was uncontrolled and of at least 145/100 mmHg, alisartan /indapamide 240/1.5mg once daily will be replaced by sacubitril alisartan 232/248mg and indapamide 1.5mg once daily. At the 3-month after the treatment, if BP was uncontrolled, amlodipine will be uptitrated to 5mg twice a day. The duration of the follow-up after randomisation will be 6 months.

Procedure: Sham

Interventions

Perirenal adipose tissue modification by focused power ultrasound PROCEDURE

Perirenal adipose tissue modification by focused power ultrasound at both kidneys

Perirenal adipose tissue modification by focused power ultrasound

Sham PROCEDURE

Sham procedure of focused ultrasound at both kidneys

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: men or women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18-75 years old;
• h 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);
• 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);
• Be willing to participate in the trial, and be able to visit doctors by himself or herself;
• Sign the informed consent form.

You may not qualify if:

• Secondary hypertension;
• Occurrence of myocardial infarction, malignant arrhythmia, severe renal failure, or stroke within 6 months;
• Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings);
• Alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin (TBL) above twice the normal range; eGFR (CKD-EPI) \<45mL/min/1.73m2;
• Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (glycated hemoglobin ≥8.5%);
• Single functionally normal kidney or presence of renal malignant tumor;
• Bilateral skin diseases at renal region that are not suitable for the therapy;
• Women in pregnancy, lactating, or planning for pregnancy;
• Other concomitant diseases that are considered not suitable for participation in the trial;
• Patients have contraindications to angiotensin receptor-neprilysin inhibitor (ARNIs), thiazide-like diuretic drugs, or calcium channel blocker (CCBs);
• Non-compliant patients.

Sponsors & Collaborators

• Yan Li: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Yan Li, Professor

CONTACT

021-64370045; liyanshcn@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Doctor of Medicine, Doctor of Philosophy

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (1)