Essential HypertensionNCT07051811
To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
A study testing Intravascular Ultrasound Ablation Therapy and Renal Artery Angiography in people with Essential Hypertension, run by Lepu Medical Technology (Beijing) Co., Ltd. at 18 sites in China.
Trial summary
This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Intravascular Ultrasound Ablation Therapy and Renal Artery Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 18 sitesChina
- Study dates
- 25 Feb 2025to 31 Dec 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and ≤75 years, regardless of gender.
- Documented history of primary hypertension.
- Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:
- Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg;
- Office diastolic blood pressure (DBP) ≥90 mmHg;
- 24-hour ambulatory systolic blood pressure ≥135 mmHg and <170 mmHg.
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.
Who cannot join
- Unsuitable Renal Artery Anatomy for Treatment
- Main renal artery diameter <4 mm or length <20 mm.
- Accessory renal artery diameter ≥ 2 mm and <4 mm.
- Renal artery stenosis >50% in the main renal artery.
- Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
- Presence of a renal artery stent.
Show all 19Show fewer
- Single kidney.
- Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m².
- Diagnosis of Type 1 Diabetes Mellitus.
- Orthostatic Hypotension.
- Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
- Suspected Secondary Hypertension.
- Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
- Prior Renal Artery Denervation Procedure.
- Life Expectancy <1 Year.
- Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
- Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
- Allergy to Contrast Agents.
- Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Beijing Anzhen hospital , Capital Medical University
Beijing, Beijing Municipality, 100029
Professor Cai, +86 010-64412431, yb@yahoo.com.cn
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zheng Professor, +86 010-53236424, zryhyyjyc@sina.com
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Li&Zheng Professor, +86 010-83572211, jgbgs090101@126.com
- Recruiting
Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100035
Liu Professor, +86 010-58516688, jishuitan3@wjw.beijing.gov.cn
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Zhang Professor, +86 010-56112345, suggestions@btch.edu.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Chen Professor, +86-28-8542-2114, hxyyyb@wchscu.cn
- Recruiting
The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 408599
Professor Huang, +86 023-63693083, ykdxdeyy@public.cta.cq.cn
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310030
Mao Professor, +86 0571-81595111, zjyyyb@126.com
- Recruiting
Inner Mongolia People's Hospital
Hohhot, Neimenggu, 010017
Cui Professor, +86 0471-3283999, gcp6621177@126.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Bu Professor, +86-531-8216 9114, yxyz@email.sdu.edu.cn
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu, 730030
Yu Professor, +86 0931-8942266, ldeyyzbgs@lzu.edu.cn
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Zhang Professor, +86 021-38804518, service@dfhospital.com
- Not yet recruiting
Shenzhen University General Hospital
Shenzhen, Guangdong, 518055
Yin Professor, +86-755-2180 2333, 3307138357@qq.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Yuan Professor, +86 029-85323333, xayyyljd@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Xie Professor, +86-592-213 2222, xmdxhyx@163.com
- Recruiting
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810001
Ren Professor, +86 0971-6162000, qdfyyzyx@163.com
- Recruiting
Yinchuan First People's Hospital
Yinchuan, Ningxia, 750001
Chen Professor, +86 0951-6192261, jw@nxmu.edu.cn
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Liu Professor, +86-371-6558 0001, menzhenban2301@163.com
About this study
Official title: A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension
This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.
Read the detailed description
This trial adopts a prospective, multicenter, randomized controlled design to validate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension. Subjects who signed the informed consent form will enter the screening phase and undergo a run-in period for 4-week of standardized medication regimen. Specifically, their current antihypertensive treatment will be uniformly replaced with a combination of an angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) (Valsartan/Amlodipine 80:5 mg) or a triple combination of ARB/CCB (Valsartan/Amlodipine 80:5 mg) plus a diuretic (Hydrochlorothiazide 12.5mg) . If the subject's office systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg during the run-in period, the investigator may adjust the medication and restart a run-in period of ≥28 days. Blood pressure will be re-evaluated, and subjects failed to meet the inclusion criteria after adjustment will be excluded.
Subjects meeting the inclusion criteria and not violating exclusion criteria will be randomized in a 2:1 ratio to either the treatment group or the control group. The treatment group will undergo intravascular ultrasound ablation therapy, while the control group will only undergo renal artery angiography. Both groups will maintain the standardized medication regimen for 6 months post-procedure (if a subject's office SBP exceeds 180 mmHg or drops below 110 mmHg in three consecutive measurements spaced 1 hour apart, the investigator may adjust the medication and record their blood pressure before the adjustment).
The primary efficacy endpoint is the change in 24-hour average ambulatory systolic blood pressure at 6 months post-procedure. Results will be analyzed using a superiority testing hypothesis to demonstrate that the treatment group achieves significantly greater reduction in 24-hour mean ambulatory systolic blood pressure compared to the control group at 6-month follow-up. During follow-up, office blood pressure, 24-hour ambulatory blood pressure, medication usage, safety events, and adverse events will be recorded for both groups.
- Conditions
- Essential Hypertension
- Being tested
- Intravascular Ultrasound Ablation Therapy, Renal Artery Angiography
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular Ultrasound Ablation TherapyProcedure or surgery
The single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves.
Standardized medication regimen.
Renal Artery AngiographyProcedure or surgery
Only undergo renal artery angiography. Standardized medication regimen.
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation (RDN) Group | Experimental | Receive standardized treatment with a minimum of two drugs and renal denervation treatments (RDN) Receives: Procedure: Intravascular Ultrasound Ablation Therapy |
| Control Group | Sham comparator | Receive standardized treatment with a minimum of two drugs and renal artery angiography only Receives: Procedure: Renal Artery Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure]
Measured: From baseline to 6 months
Secondary outcomes (8)
Change in Daytime/Nighttime Average Ambulatory Systolic Blood Pressure (SBP)
Measured: 1 Month, 2 Months, and 6 Months Post-Procedure
Change in 24-Hour/Daytime/Nighttime Average Ambulatory Diastolic Blood Pressure (DBP)
Measured: 1 Month, 2 Months, and 6 Months Post-Procedure
Change in 24-Hour Average Ambulatory Systolic Blood Pressure (SBP)
Measured: 1 Month and 2 Months Post-Procedure
Change in Office Systolic Blood Pressure
Measured: 1 Month, 2 Months, and 6 Months Post-Procedure
Change in Office Diastolic Blood Pressure
Measured: 1 Month, 2 Months, and 6 Months Post-Procedure
Achievement Rate of Target Office Systolic Blood Pressure
Measured: 1 Month, 2 Months, and 6 Months Post-Procedure
Composite Index of Antihypertensive Medication Use
Measured: 1 Month, 2 Months, and 6 Months Post-Procedure
Proportion of Subjects with ≥5 mmHg Reduction in 24-Hour Average Ambulatory Systolic Blood Pressure
Measured: 6 Months Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start25 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051811
- Sponsor's protocol ID
- LPCTP-2021-004(CT)
- Status last verified
- Feb 2025
- First submitted
- 24 Jun 2025
- Last updated
- 4 Jul 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension
- ClinicalTrials.gov ID
- NCT07051811
- Acronym / sponsor ID
- LPCTP-2021-004(CT)
- Conditions
- Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jul 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.
This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.
Detailed description
This trial adopts a prospective, multicenter, randomized controlled design to validate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension. Subjects who signed the informed consent form will enter the screening phase and undergo a run-in period for 4-week of standardized medication regimen. Specifically, their current antihypertensive treatment will be uniformly replaced with a combination of an angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) (Valsartan/Amlodipine 80:5 mg) or a triple combination of ARB/CCB (Valsartan/Amlodipine 80:5 mg) plus a diuretic (Hydrochlorothiazide 12.5mg) . If the subject's office systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg during the run-in period, the investigator may adjust the medication and restart a run-in period of ≥28 days. Blood pressure will be re-evaluated, and subjects failed to meet the inclusion criteria after adjustment will be excluded.
Subjects meeting the inclusion criteria and not violating exclusion criteria will be randomized in a 2:1 ratio to either the treatment group or the control group. The treatment group will undergo intravascular ultrasound ablation therapy, while the control group will only undergo renal artery angiography. Both groups will maintain the standardized medication regimen for 6 months post-procedure (if a subject's office SBP exceeds 180 mmHg or drops below 110 mmHg in three consecutive measurements spaced 1 hour apart, the investigator may adjust the medication and record their blood pressure before the adjustment).
The primary efficacy endpoint is the change in 24-hour average ambulatory systolic blood pressure at 6 months post-procedure. Results will be analyzed using a superiority testing hypothesis to demonstrate that the treatment group achieves significantly greater reduction in 24-hour mean ambulatory systolic blood pressure compared to the control group at 6-month follow-up. During follow-up, office blood pressure, 24-hour ambulatory blood pressure, medication usage, safety events, and adverse events will be recorded for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation (RDN) Group | Experimental | Procedure: Intravascular Ultrasound Ablation TherapyReceive standardized treatment with a minimum of two drugs and renal denervation treatments (RDN) |
| Control Group | Sham comparator | Procedure: Renal Artery AngiographyReceive standardized treatment with a minimum of two drugs and renal artery angiography only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years and ≤75 years, regardless of gender.
- Documented history of primary hypertension.
- Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.
Key exclusion criteria (19 listed)
- Unsuitable Renal Artery Anatomy for Treatment
- Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m².
- Diagnosis of Type 1 Diabetes Mellitus.
- Orthostatic Hypotension.
- Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
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 |
|---|---|---|
| Intravascular Ultrasound Ablation TherapyThe single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves. Standardized medication regimen. | Procedure or surgery | Renal denervation (RDN) Group |
| Renal Artery AngiographyOnly undergo renal artery angiography. Standardized medication regimen. | Procedure or surgery | Control Group |
Primary outcome
Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure]
Time frame: From baseline to 6 months
8 secondary outcomes
Change in Daytime/Nighttime Average Ambulatory Systolic Blood Pressure (SBP)
Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure
Change in 24-Hour/Daytime/Nighttime Average Ambulatory Diastolic Blood Pressure (DBP)
Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure
Change in 24-Hour Average Ambulatory Systolic Blood Pressure (SBP)
Time frame: 1 Month and 2 Months Post-Procedure
Change in Office Systolic Blood Pressure
Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure
Change in Office Diastolic Blood Pressure
Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure
Achievement Rate of Target Office Systolic Blood Pressure
Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure
Composite Index of Antihypertensive Medication Use
Time frame: 1 Month, 2 Months, and 6 Months Post-Procedure
Proportion of Subjects with ≥5 mmHg Reduction in 24-Hour Average Ambulatory Systolic Blood Pressure
Time frame: 6 Months Post-Procedure
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 4 Jul 2025.
- Individual participant dataSharing planned: No
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Ultrasound Ablation Therapy and Renal Artery Angiography in people with Essential Hypertension, run by Lepu Medical Technology (Beijing) Co., Ltd. at 18 sites 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 7 inclusion and 19 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure] (time frame: From baseline to 6 months). 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 4 Jul 2025.