Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN

NCT06877221 | Recruiting

• 1 other identifier: MW-URDN202501
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible subjects are randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group is treated with the ultrasound nerve ablation catheter and the ultrasound nerve ablation device of Shenzhen Maiwei Medical Technology Co., Ltd., while the control group only undergoes renal arteriography (regarded as a sham operation). Within 6 months after the operation, both groups continue to receive antihypertensive drug treatment with the dosage and types specified during the screening period. The subjects are kept blinded during the study. The relative change values of the average 24 - hour ambulatory systolic blood pressure from the baseline at 6 months after the operation are compared between the two groups.

Conditions

Refractory Hypertension or Drug-intolerant Hypertension

Outcome Measures

Primary Outcomes (1)

• The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline

  The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline at 6 months after surgery

  Six months after surgery

Secondary Outcomes (6)

• The change values of clinic systolic blood pressure and diastolic blood pressure relative to the baseline

  3 months and 6 months after surgery

• The attainment rate of clinic diastolic blood pressure

  3 months and 6 months after surgery

• The average change value of 24 - hour ambulatory diastolic blood pressure relative to the baseline

  3 months and 6 months after surgery

• The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline

  Three months after surgery

• The proportion of patients with a reduction in clinic systolic blood pressure of ≥5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg

  3 months and 6 months after surgery

Study Arms (2)

ultrasound renal denervation

EXPERIMENTAL

Procedure: ultrasound renal denervation

Renal arteriography

SHAM COMPARATOR

Procedure: ultrasound renal denervation

Interventions

ultrasound renal denervation PROCEDURE

Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device

Renal arteriography; ultrasound renal denervation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years old (calculated based on the date of starting standardized medication).
• 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).
• Resting heart rate ≥70 beats per minute without taking beta - blockers (this criterion does not apply to patients taking beta - blockers).
• 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

You may not qualify if:

• 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).
• Having only one kidney or having received a kidney transplant.
• Having a history of renal artery interventional treatment or renal denervation surgery.
• 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.
• Secondary hypertension (excluding apnea syndrome).
• Glomerular filtration rate (eGFR) \< 45 mL/min/1.73m² (MDRD formula).
• Having a history of hospitalization due to hypertensive crisis within one year before randomization for enrollment.
• Suffering from type 1 diabetes.
• Suffering from primary pulmonary hypertension.
• Being allergic to contrast agents.
• Severe cardiac valve stenosis.
• Cardiac insufficiency (NYHA class III - IV).
• Hyperthyroidism or hypothyroidism.
• Requiring mechanical ventilation for assisted breathing (except for nocturnal respiratory support for treating sleep apnea).
• Acute or severe systemic infection.

Sponsors & Collaborators

• Shenzhen Pulsecare Medical Technology Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jingfeng J wang, Postdoctoral fellow

CONTACT

020-81332199; wangjingfeng2017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: January 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)