Resistant HypertensionPhase 3PATH-RHTNCT07232966
Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension
A Phase 3 study testing Perirenal adipose tissue modification by focused power ultrasound in people with Resistant Hypertension, run by Yan Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Perirenal adipose tissue modification by focused power ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2025to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18-75 years old;
- 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);
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Yan Li, Professor, 021-64370045 ext. 675101, liyanshcn@163.com
Yan Li, Professor
About this study
Official title: The Efficacy and Safety of Perirenal Adipose Tissue Modification Therapy by Focused Power Ultrasound for Resistant Hypertension
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.
Read the 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
- Being tested
- Perirenal adipose tissue modification by focused power ultrasound, Sham
- Keywords
- perirenal adipose tissue, focused ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perirenal adipose tissue modification by focused power ultrasoundProcedure or surgery
Perirenal adipose tissue modification by focused power ultrasound at both kidneys
ShamProcedure or surgery
Sham procedure of focused ultrasound at both kidneys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in 24h systolic blood pressure at the 6-month after treatment
Measured: 6 months after treatment
Secondary outcomes (7)
Reduction in 24h ambulatory systolic/diastolic blood pressure
Measured: 1 month after treatment
Reductions in 24h ambulatory systolic/diastolic blood pressure
Measured: 3 months after treatment
Reduction in 24h ambulatory diastolic blood pressure
Measured: 6 months after treatment
Reduction in clinic systolic/diastolic blood pressure
Measured: 1 month after treatment
Reduction in clinic systolic/diastolic blood pressure
Measured: 3 months after treatment
Reduction in clinic systolic/diastolic blood pressure
Measured: 6 months after treatment
Drug burden of antihypertensive treatment
number of drugs * dosage of drugs
Measured: 6 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Li, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232966
- Sponsor's protocol ID
- 2025148
- Acronym
- PATH-RHT
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Perirenal Adipose Tissue Modification Therapy by Focused Power Ultrasound for Resistant Hypertension
- ClinicalTrials.gov ID
- NCT07232966
- Acronym / sponsor ID
- PATH-RHT / 2025148
- Conditions
- Resistant Hypertension
- Keywords
- perirenal adipose tissue, focused ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Yan LiUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perirenal adipose tissue modification by focused power ultrasound | Experimental | Procedure: Perirenal adipose tissue modification by focused power ultrasoundPerirenal 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. |
| Sham | Sham comparator | Procedure: ShamSham 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 18-75 years old;
- 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);
- 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.
Key exclusion criteria (11 listed)
- 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%);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perirenal adipose tissue modification by focused power ultrasoundPerirenal adipose tissue modification by focused power ultrasound at both kidneys | Procedure or surgery | Perirenal adipose tissue modification by focused power ultrasound |
| ShamSham procedure of focused ultrasound at both kidneys | Procedure or surgery | Sham |
Primary outcome
Reduction in 24h systolic blood pressure at the 6-month after treatment
Time frame: 6 months after treatment
7 secondary outcomes
Reduction in 24h ambulatory systolic/diastolic blood pressure
Time frame: 1 month after treatment
Reductions in 24h ambulatory systolic/diastolic blood pressure
Time frame: 3 months after treatment
Reduction in 24h ambulatory diastolic blood pressure
Time frame: 6 months after treatment
Reduction in clinic systolic/diastolic blood pressure
Time frame: 1 month after treatment
Reduction in clinic systolic/diastolic blood pressure
Time frame: 3 months after treatment
Reduction in clinic systolic/diastolic blood pressure
Time frame: 6 months after treatment
Drug burden of antihypertensive treatment
Time frame: 6 months after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Perirenal adipose tissue modification by focused power ultrasound in people with Resistant Hypertension, run by Yan Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, Professor (021-64370045 ext. 675101, liyanshcn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in 24h systolic blood pressure at the 6-month after treatment (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.