Modulated ultrasound renal denervation for refractory or drug‑intolerant high blood pressure

A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of an Ultrasound Renal Denervation Catheter in Combination With an Ultrasound Renal Denervation Device for the Treatment of Refractory Hypertension or Drug - Intolerant Hypertension

This trial will test whether an ultrasound kidney nerve‑ablation procedure can lower blood pressure in adults whose hypertension is hard to control or who cannot tolerate blood‑pressure drugs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shenzhen Pulsecare Medical Technology Co., Ltd. (industry)
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06877221 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized, blinded trial that assigns eligible participants 2:1 to receive ultrasound renal denervation or a sham renal arteriography procedure. Participants stabilize on a prescribed antihypertensive regimen for at least four weeks before randomization and continue the same medications for six months after the procedure. The primary outcome is the relative change in average 24‑hour ambulatory systolic blood pressure from baseline to six months. The study compares blood‑pressure changes between the active and sham groups to see if the ultrasound ablation provides greater sustained lowering.

Who should consider this trial

Good fit: Adults aged 18–70 who have been on at least two antihypertensive drugs for four weeks or more with clinic systolic blood pressure 140–180 mmHg and average 24‑hour systolic blood pressure ≥130 mmHg (or daytime ≥135 mmHg), and who agree to the protocol and consent process.

Not a fit: Patients with renal artery anatomy unsuitable for ablation (for example >50% renal artery stenosis, renal artery aneurysm, or fibromuscular dysplasia), or those outside the specified blood‑pressure or age ranges, are unlikely to benefit from this procedure in the trial.

Why it matters

Potential benefit: If successful, the procedure could lower blood pressure and potentially reduce the need for multiple antihypertensive medications in people with hard‑to‑control or drug‑intolerant hypertension.

How similar studies have performed: Previous randomized trials of renal denervation, including trials using endovascular ultrasound, have shown modest but clinically meaningful reductions in ambulatory systolic blood pressure in some patient groups.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
2. After treatment with at least two types of antihypertensive drugs for 4 weeks or more, the clinic systolic blood pressure is ≥140 mmHg and ≤180 mmHg, and the average 24 - hour ambulatory systolic blood pressure is ≥130 mmHg (or the daytime ambulatory systolic blood pressure is ≥135 mmHg).
3. Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
4. The subject agrees to participate in this clinical trial, complies with the follow - up required by the trial protocol, and has voluntarily signed the informed consent form

Exclusion Criteria:

1. CTA, MRA, or DSA examination shows that the shape and structure of the unilateral or bilateral renal arteries are not suitable for ablation surgery (renal artery stenosis exceeding 50%, renal artery aneurysm, fibromuscular dysplasia of the renal artery, or the diameter of the main renal artery is less than 3 mm).
2. Having only one kidney or having received a kidney transplant.
3. Having a history of renal artery interventional treatment or renal denervation surgery.
4. Suffering from any condition that may affect the accuracy of blood pressure measurement, such as the upper arm diameter being too large relative to the cuff.
5. Secondary hypertension (excluding apnea syndrome).
6. Glomerular filtration rate (eGFR) \< 45 mL/min/1.73m² (MDRD formula).
7. Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
8. Suffering from type 1 diabetes.
9. Suffering from primary pulmonary hypertension.
10. Being allergic to contrast agents.
11. Severe cardiac valve stenosis.
12. Cardiac insufficiency (NYHA class III - IV).
13. Hyperthyroidism or hypothyroidism.
14. Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
15. Acute or severe systemic infection.
16. Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
17. Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
18. Having obvious bleeding tendency and hematological diseases.
19. Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
20. Having a cardiovascular event (stable or unstable angina, myocardial infarction) or cerebrovascular event (stroke, cerebrovascular accident, transient ischemic attack) within 6 months before randomization for enrollment.
21. Pregnant, lactating women, or women planning to become pregnant during the study period.
22. Currently participating in other clinical trials of drugs or medical devices.
23. Other reasons that the investigator deems inappropriate for participation in this study

Where this trial is running

Guangzhou

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Jingfeng J wang, Postdoctoral fellow

Conditions: Refractory Hypertension or Drug-intolerant Hypertension