Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis
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- STATUS
- Recruiting
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- End date
- Dec 31, 2023
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- participants needed
- 30
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- sponsor
- The Second Hospital of Nanjing Medical University
Summary
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.
Description
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.
Details
| Condition | Vascular Diseases, Vascular Diseases, Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Diabetes and Hypertension, Hemodialysis, Hemodialysis, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension |
|---|---|
| Treatment | SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator |
| Clinical Study Identifier | NCT04872114 |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Last Modified on | 11 May 2021 |
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