Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Uncontrolled treatment resistant hypertension (despite intake of 3 different classes of antihypertensive medications) confirmed by 24-h ambulatory blood pressure according to current guidelines (ESH 2023) (office blood pressure ≥ 140/ and/ or ≥ 90 mmHg and ambulatory blood pressure ≥ 130/ and/or ≥ 80 mmHg
end-stage renal disease on chronic hemodialysis
Stable hemodialysis regime for at least 3 months based on the decision of the treating physician
Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks.
Disqualifiers
Episodes of sustained systolic and/or diastolic hypotension according to 24-h ambulatory blood pressure or dialysis protocols which in the eyes of the treating physician would interfere with a safe renal denervation treatment of the patient
Known hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement
Prior renal denervation procedure
Anatomic or functional solitary kidney, kidney transplantation
Trial design
Design model
Single group
Treatments tested in this trial
renal denervation
Deviceultrasound based renal denervation
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: TreatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Safety endpoints and adverse effects
A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU
Time frame
during 6 months post-procedure2
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure
Time frame
baseline and 3 months post-procedureSecondary outcomes
1
Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure
Time frame
between baseline and 6 months post-procedure.2
Change in 24-h ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure
Time frame
baseline and 3, 6 months post-procedure.3
Change in office (attended) systolic and diastolic blood pressure between baseline and 3, 6 months post-procedure
Time frame
between baseline and 3, 6 months post-procedure4
Change in systolic and diastolic home blood pressure between baseline and 3, 6 months post-procedure.
Time frame
between baseline and 3, 6 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov