renal denervation: ultrasound based renal denervation
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Primary outcome measure(s)
Safety endpoints and adverse effects — during 6 months post-procedure A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure — baseline and 3 months post-procedure
Trial sites (1)
Facility
City
Region
Status
Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension
Erlangen
Bavaria
Recruiting
More University of Erlangen-Nürnberg Medical School trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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