NCT04872114

Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis

A Prospective, Single-center, Open-label, Self Controlled Case Series Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension in Patients on Hemodialysis (SMART-HD Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hypertension
• Hemodialysis

Interventions

Type	Name	Description
DEVICE	SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator	Radiofrequency ablation of renal arterial sympathetic nerves

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-05-01
• Completion: 2023-12-31
• First posted: 2021-05-04
• Last updated: 2021-05-04

Locations

1 site across 1 country: China