Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
Recruiting · NCT06556407 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Erlangen-Nürnberg Medical School
View the official record on ClinicalTrials.gov →Interventions studied
renal denervation
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension - Erlangen, Bavaria, Germany