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Clinical Trials in Germany / NCT06556407
Recruiting Not applicable

Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis

NCT06556407 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-03-04
Last updated
2025-09-26

Condition(s) studied

Treatment Resistant HypertensionChronic Hemodialysis

Investigational drug(s) / intervention(s)

renal denervation

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)

Trial sites (1)

FacilityCityRegionStatus
Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension Erlangen Bavaria Recruiting

More University of Erlangen-Nürnberg Medical School trials in Germany

Official registry record

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.

View NCT06556407 on ClinicalTrials.gov ↗ ← All trials in Germany