Refractory Hypertension or Drug-intolerant HypertensionModulationHTN2NCT06877221
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN
A study testing ultrasound renal denervation in people with Refractory Hypertension or Drug-intolerant Hypertension, run by Shenzhen Pulsecare Medical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Hypertension or Drug-intolerant Hypertension
- What is being tested?
- ultrasound renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
- Having an implantable cardioverter - defibrillator (ICD) or pacemaker.
- Having obvious symptoms of active peptic ulcer (such as abdominal pain, nausea, vomiting, regurgitation, etc.).
- Having obvious bleeding tendency and hematological diseases.
- Having a history of surgery or trauma requiring hospitalization within 30 days before randomization for enrollment.
- 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.
- Pregnant, lactating women, or women planning to become pregnant during the study period.
- Currently participating in other clinical trials of drugs or medical devices.
- Other reasons that the investigator deems inappropriate for participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou
Jingfeng Wang J Wang, 189 2891 6398, wangjingfeng2017@163.com
About this study
Official title: 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.
- Being tested
- ultrasound renal denervation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound renal denervationProcedure or surgery
Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device
| Study group | Role | What they receive |
|---|---|---|
| ultrasound renal denervation | Experimental | Not described Receives: Procedure: ultrasound renal denervation |
| Renal arteriography | Sham comparator | Not described Receives: Procedure: ultrasound renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months after surgery
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start25 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Hypertension or Drug-intolerant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877221
- Sponsor's protocol ID
- MW-URDN202501
- Acronym
- ModulationHTN2
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06877221
- Acronym / sponsor ID
- ModulationHTN2 / MW-URDN202501
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound renal denervation | Experimental | Procedure: ultrasound renal denervation |
| Renal arteriography | Sham comparator | Procedure: ultrasound renal denervation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound renal denervationTreat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device | Procedure or surgery | Renal arteriography, ultrasound renal denervation |
Primary outcome
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
6 secondary outcomes
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 attainment rate of clinic diastolic blood pressure
Time frame: 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 value of 24 - hour ambulatory systolic blood pressure relative to the baseline
Time frame: 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
Changes in the drug composite index of the types and dosages of antihypertensive medications
Time frame: Six months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Refractory Hypertension or Drug-intolerant Hypertension
Not yet recruiting
Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension
Refractory Hypertension or Drug-intolerant Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound renal denervation in people with Refractory Hypertension or Drug-intolerant Hypertension, run by Shenzhen Pulsecare Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingfeng J wang, Postdoctoral fellow (020-81332199 ext. 0000, wangjingfeng2017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline (time frame: Six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.