Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
NCT Number: NCT06556407
Acronym: RDN-HD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Treatment Resistant Hypertension|Chronic Hemodialysis
Interventions: DEVICE: renal denervation
Sponsor: University of Erlangen-Nürnberg Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-02
Completion Date: 2025-11-01
Locations: Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension, Erlangen, Bavaria, 91054, Germany

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.

Primary Outcome Measures: Safety endpoints and adverse effects, A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU, during 6 months post-procedure|Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure, baseline and 3 months post-procedure
Secondary Outcome Measures: Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure, between baseline and 6 months post-procedure.|Change in 24-h ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure, baseline and 3, 6 months post-procedure.|Change in office (attended) systolic and diastolic blood pressure between baseline and 3, 6 months post-procedure, between baseline and 3, 6 months post-procedure|Change in systolic and diastolic home blood pressure between baseline and 3, 6 months post-procedure., between baseline and 3, 6 months post-procedure|Number of antihypertensive drugs, doses, classes at 3, 6 months post-procedure compared to baseline., at 3, 6 months post-procedure compared to baseline.|Change in bio-impedance parameters between baseline and 3, 6 months post-procedure to assess the volume status., between baseline and 3, 6 months post-procedure|Change in central systolic and diastolic blood pressure, central pulse pressure and pulse wave velocity between baseline and 3,6 months post procedure, between baseline and 3,6 months post procedure|Change in retinal arteriolar wall to lumen ratio between baseline and 3,6 months post procedure, between baseline and 3,6 months post procedure|Change in average daytime/night-time ambulatory systolic blood pressure between baseline and 3, 6 months post-procedure., between baseline and 3, 6 months post-procedure.|Change in average daytime/night-time ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure, between baseline and 3, 6 months post-procedure|Change in office (attended) and ambulatory heart rate between baseline and 3, 6 months post-procedure, between baseline and 3, 6 months post-procedure|Changes in dipper/non-dipper patterns between baseline and 3, 6 months post-procedure, between baseline and 3, 6 months post-procedure|Change in retinal arterial remodeling between baseline and 3, 6 months post-procedure, between baseline and 3, 6 months post-procedure|Change in retinal capillary density between baseline and 3, 6 months post-procedure, between baseline and 3, 6 months post-procedure