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| Name | Class |
|---|---|
| SyMap Medical (Suzhou), Ltd. | INDUSTRY |
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To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients on hemodialysis with pharmacotherapy and uncontrolled hypertension for at least 6 months, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.
This is a prospective, single-center, open-label, self controlled case series trial, in which patients on maintenance hemodialysis are diagnosed with essential hypertension with at least six months of disease history and pharmacotherapy however their blood pressure still cannot be controlled. The patients will be informed, consent and get into a screening process. During the screening period patients will receive a standardized antihypertensive drug treatment for at least 28 days and office BP is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography followed by renal sympathetic nerve denvervation (30 patients). Patients with office BP which is not achieved ideal level (<140 mmHg) will titrate doses of classes of antihypertensive drugs according to a predefined standardized medication regimen until their office BP <140 mmHg.
Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 3 months and 6 months. Blood samples will be collected for drug tests to determine drug compliance of a patient.
Data collecting/management/statistical analysis and laboratory tests will be performed by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Sympathetic Denervation | Experimental | Percutaneous renal denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator | Device | Radiofrequency ablation of renal arterial sympathetic nerves |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in office BP | Reduction in office BP at 3 month after the treatment | 3 month after the treatment |
| The composite index of anti-hypertensive drugs | The composite index of anti-hypertensive drugs at 6 months after the treatments | 6 months after the treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in office BP | Reduction in office BP at 1 month and 6 months after the treatment | 1 month, 6 months |
| Postoperative reduction in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) reduction in systolic, diastolic and mean arterial blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wang, MD, PhD | Contact | +8613511604566 | jay329329@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210003 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011876 | Radionuclide Generators |
| ID | Term |
|---|---|
| D055618 | Radiation Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 1 month, 3 months, 6 months |
| The control rates of reduction in office systolic blood pressure (SBP) by 10mmHg or Ambulatory Systolic Blood Pressure (ASBP) by 5mmHg | 1 month, 3 months, 6 months |
| The control rates of office systolic blood pressure ( SBP<140mmHg) | The control rates of office systolic blood pressure ( SBP<140mmHg) at 6 month after the treatment | 6 month |
| Incidence of Intradialytic hypotension (IDH) | Decrease in systolic BP of ≥ 20 mm Hg during hemodialysis | 1 month, 3 months, 6 months |
| All-cause death | 1 month, 3 months, 6 months |
| AEs, SAEs, and severe cardio-cerebrovascular events | 1 month, 3 months, 6 months |
| Success rate of the renal interventional therapy procedure | the renal denervation catheter can be engaged to the correct position in renal artery, successfully performed renal nerve ablation procedure and has no related complications such as renal arterial perforation | during the procedure |
| Success rate of clinical treatment | based on succeed performance of renal interventional therapy procedure , there are no the procedure-related SAE, such as acute infection and renal dysfunction | 7 days after the procedure or at the time the patient is discharged from hospital |
| Rate of renal artery stenosis assessed by CT angiography | stenosis > 70% | 6 months |