Renal nerve ablation for treating high blood pressure

An Exploratory Clinical Study on the Safety and Efficacy of the Ultrasonic Nerve Ablation System in the Treatment of Essential Hypertension

This study is testing a new procedure that uses ultrasound to target nerves in the kidneys to see if it can help people with high blood pressure who are already on medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shenzhen Pulsecare Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06877234 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and effectiveness of renal endovascular nerve elimination in patients with essential hypertension. It will enroll a total of 6 subjects who have been on stable antihypertensive medication for at least 4 weeks and meet specific blood pressure criteria. Participants will undergo renal artery CTA angiography and will be monitored for blood pressure changes during and after the procedure over a period of 6 months. The intervention involves the use of an Ultrasonic Nerve Ablation System to target renal nerves associated with hypertension.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with essential hypertension who have been on multiple antihypertensive medications.

Not a fit: Patients with type 1 diabetes or uncontrolled type 2 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with resistant hypertension.

How similar studies have performed: While this approach is exploratory, similar interventions in other studies have shown promise in managing hypertension.

Eligibility criteria

Inclusion Criteria:

Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;

Exclusion Criteria:

Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;

Preoperative exclusion criteria based on CTA imaging:

a. Visual inspection shows that the diameter stenosis of the renal artery on either side \> 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.

Where this trial is running

Guangzhou, Guangdong

• the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital） — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jingfeng J wang, Postdoctoral fellow

Conditions Essential Hypertension