Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis (NCT06556407) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
Germany12 participantsStarted 2024-03-04
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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 mo…
What they're measuring
1
Safety endpoints and adverse effects
Timeframe: during 6 months post-procedure
2
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure
Timeframe: baseline and 3 months post-procedure
Trial details
NCT IDNCT06556407
SponsorUniversity of Erlangen-Nürnberg Medical School