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

June 16, 2025 updated by: Shenzhen Pulsecare Medical Technology Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline
Time Frame: Six months after surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change values of clinic systolic blood pressure and diastolic blood pressure relative to the baseline
Time Frame: 3 months and 6 months after surgery
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
Time Frame: 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 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
Time Frame: 3 months and 6 months after surgery
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
Time Frame: Three months after surgery
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
Time Frame: 3 months and 6 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 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
Time Frame: Six months after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen Pulsecare Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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