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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound renal denervation | Experimental |
| |
| Renal arteriography | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound renal denervation | Procedure | Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingfeng J wang, Postdoctoral fellow | Contact | 020-81332199 | 0000 | wangjingfeng2017@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 |