RecruitingNot ApplicableNCT06556407
Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
Effect of Renal Denervation on Blood Pressure in Patients With Treatment Resistant Hypertension, End-stage Chronic Kidney Disease and Hemodialysis
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
12 participants
Start Date
Mar 4, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria5
- 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 Criteria11
- 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)
Interventions
DEVICErenal denervation
ultrasound based renal denervation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06556407