Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872114
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2021-04-29
Brief Title:
Sympathetic Mapping Ablation of Renal Nerves Trial - Hemodialysis
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
The Second Hospital of Nanjing Medical University
Study Overview
Official Title:
A Prospective Single-center Open-label Self Controlled Case Series Trial of Renal Sympathetic Denervation Using SyMapCath I Catheter and SYMPIONEER S1 StimulatorGenerator for the Treatment of Hypertension in Patients on Hemodialysis SMART-HD Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-HD
Brief 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 collectingmanagementstatistical analysis and laboratory tests will be performed by independent qualified organizations Independent DSMBCEC are formed and responsible for assessments of protocol deviations and natures of SAEs
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 collectingmanagementstatistical analysis and laboratory tests will be performed by independent qualified organizations Independent DSMBCEC are formed and responsible for assessments of protocol deviations and natures of SAEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None