Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556407
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Renal Denervation on Blood Pressure in Patients With Treatment Resistant Hypertension End-stage Chronic Kidney Disease and Hemodialysis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RDN-HD
Brief Summary:
The RDN-HD Study is a prospective single-center feasibility study All patients included will undergo endovascular ultrasound-based RDN no sham group no blinding The purpose of the RDN-HD Study is to demonstrate that ultrasound-based RDN is safe in patients with TRH and ESRD hemodialysis and reduces 24-h ambulatory BP
Detailed Description:
Patients with end-stage renal disease ESRD and hemodialysis have a very high risk for cardiovascular events and a very high cardiovascular mortality Uncontrolled treatment resistant hypertension TRH is an important factor driving this very high cardiovascular event risk Clinical and experimental studies have clearly shown that sympathetic nerve activity is increased in patients with chronic kidney disease CKD and substantially aggravates the progression of CKD In patients with ESRD and chronic hemodialysis bilateral nephrectomy reduced increased sympathetic nerve activity Interestingly kidney transplantation did not normalize peripheral sympathetic activity unless the native kidneys were removed Thus afferent sensory nerve signaling from the diseased kidneys to the central nervous system is an important pathophysiologic mechanism in CKD leading to sympathetic overactivity and hypertension Clinical studies have demonstrated that invasive catheter-based renal denervation RDN decreases the sympathetic nerve activity in the whole body and in particular in the kidneys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None