Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis

NCT ID: NCT06556407

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-04
• Study Completion Date: 2026-12-01

Brief 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.

Detailed 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

Conditions

Treatment Resistant Hypertension; Chronic Hemodialysis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Intervention: Renal denervation

Group Type: OTHER

renal denervation

Intervention Type: DEVICE

ultrasound based renal denervation

Interventions

renal denervation

ultrasound based renal denervation

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Agnes Bosch, MD

Role: CONTACT

agnes.bosch@uk-erlangen.de

+49 9131 8536207

Roland E. Schmieder, MD

Role: CONTACT

roland.schmieder@uk-erlangen.de

+499131 8536207

Facility Contacts

Agnes Bosch, MD

Role: primary

agnes.bosch@uk-erlangen.de

+49 9131 8536216

Other Identifiers

23-388-MDz

Identifier Type: -

Identifier Source: org_study_id