A Phase 3 interventional study of Perirenal adipose tissue modification by focused power ultrasound and Sham in Resistant Hypertension, sponsored by Yan Li. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Yan Li · Phase 3, Interventional, and Treatment
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 220 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Yan Li is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Perirenal adipose tissue modification by focused power ultrasound at both kidneys
Sham procedure of focused ultrasound at both kidneys
Reduction in 24h systolic blood pressure at the 6-month after treatment
Time frame: 6 months after treatment
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
number of drugs \* dosage of drugs
Time frame: 6 months after the treatment
The incidence rate of all-cause death
Time frame: 6 months after treatment
The incidence of cardiovascular events
Time frame: 6 months after treatment
The incidence of renal failure
Time frame: 6 months after treatment
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yan Li