Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis (RDN-HD)

University of Erlangen-Nürnberg Medical School

Status

Enrolling

Conditions

Chronic Hemodialysis

Treatment Resistant Hypertension

Treatments

Device: renal denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT06556407

Prüfplan 1.2

Details and patient eligibility

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.

Full description

Patients with end-stage renal disease (ESRD) and hemodialysis have a very high risk for cardiovascular events and a very high cardiovascular mortality. Uncontrolled treatment resistant hypertension (TRH) is an important factor driving this very high cardiovascular event risk. Clinical and experimental studies have clearly shown that sympathetic nerve activity is increased in patients with chronic kidney disease (CKD) and substantially aggravates the progression of CKD. In patients with ESRD and chronic hemodialysis bilateral nephrectomy reduced increased sympathetic nerve activity. Interestingly, kidney transplantation did not normalize peripheral sympathetic activity unless the native kidneys were removed. Thus, afferent sensory nerve signaling from the diseased kidneys to the central nervous system is an important pathophysiologic mechanism in CKD leading to sympathetic overactivity and hypertension. Clinical studies have demonstrated that invasive, catheter-based renal denervation (RDN) decreases the sympathetic nerve activity in the whole body and in particular in the kidneys

Enrollment

12 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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 ≥ 140/90 mmHg and ambulatory blood pressure ≥ 130/80 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)