Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis

Recruiting now · Not applicable

Conditions studied: Treatment Resistant Hypertension, Chronic Hemodialysis

In brief

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.

Key facts

Study ID: NCT06556407
Run by: University of Erlangen-Nürnberg Medical School
People needed: 12
Starts: 2024-03-04
Expected to finish: 2026-12-01
Last updated by the study team: 2025-09-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Individual is ≥ 18 years of age, male and female patients are included.

You may not qualify if…

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
Severe atherosclerotic disease or artery calcification preventing the assessment of reliable BP measurements
Endocrine hypertension other than obstructive sleep apnea
Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit
Acute episode of systemic and renal disease requiring uptitration of any immunosuppressive drug regimen within the last 3 months
Subject is pregnant, nursing, or intends to become pregnant
Enrollment in another interventional research protocol.
Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)

Where it is running

Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension — Erlangen, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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