Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN (ModulationHTN2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Hypertension or Drug-intolerant Hypertension
• Intervention / Treatment: Procedure: ultrasound renal denervation

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingfeng J wang, Postdoctoral fellow; Phone Number: 0000 020-81332199; Email: wangjingfeng2017@163.com

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Contact: Jingfeng Wang J Wang; Phone Number: 189 2891 6398; Email: wangjingfeng2017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasound renal denervation	Procedure: ultrasound renal denervation; Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device
Sham Comparator: Renal arteriography	Procedure: ultrasound renal denervation; Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change values of clinic systolic blood pressure and diastolic blood pressure relative to the baseline	The changes in clinic systolic and diastolic blood pressures relative to the baseline at 3 months and 6 months after surgery	3 months and 6 months after surgery
The attainment rate of clinic diastolic blood pressure	The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery	3 months and 6 months after surgery
The average change value of 24 - hour ambulatory diastolic blood pressure relative to the baseline	The average change values of 24 - hour ambulatory diastolic blood pressure relative to the baseline at 3 months and 6 months after surgery	3 months and 6 months after surgery
The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline	The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline at 3 months after surgery	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	The proportion of patients with a reduction in clinic systolic blood pressure of ≥ 5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg at 3 months and 6 months after surgery	3 months and 6 months after surgery
Changes in the drug composite index of the types and dosages of antihypertensive medications	Changes in the drug composite index of the types and dosages of antihypertensive drugs 6 months after surgery	Six months after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: MW-URDN202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No