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

Effect of Renal Denervation on Blood Pressure in Patients With Treatment Resistant Hypertension, End-stage Chronic Kidney Disease and Hemodialysis

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment Resistant Hypertension; Chronic Hemodialysis
• Intervention / Treatment: Device: renal denervation

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

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Bosch, MD; Phone Number: +49 9131 8536207; Email: agnes.bosch@uk-erlangen.de
• Study Contact Backup: Name: Roland E. Schmieder, MD; Phone Number: +499131 8536207; Email: roland.schmieder@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension
      • Contact: Agnes Bosch, MD; Phone Number: +49 9131 8536216; Email: agnes.bosch@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; Intervention: Renal denervation	Device: renal denervation; ultrasound based renal denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints and adverse effects	A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU	during 6 months post-procedure
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure		baseline and 3 months post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure	between baseline and 6 months post-procedure.
Change in 24-h ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure	baseline and 3, 6 months post-procedure.
Change in office (attended) systolic and diastolic blood pressure between baseline and 3, 6 months post-procedure	between baseline and 3, 6 months post-procedure
Change in systolic and diastolic home blood pressure between baseline and 3, 6 months post-procedure.	between baseline and 3, 6 months post-procedure
Number of antihypertensive drugs, doses, classes at 3, 6 months post-procedure compared to baseline.	at 3, 6 months post-procedure compared to baseline.
Change in bio-impedance parameters between baseline and 3, 6 months post-procedure to assess the volume status.	between baseline and 3, 6 months post-procedure
Change in central systolic and diastolic blood pressure, central pulse pressure and pulse wave velocity between baseline and 3,6 months post procedure	between baseline and 3,6 months post procedure
Change in retinal arteriolar wall to lumen ratio between baseline and 3,6 months post procedure	between baseline and 3,6 months post procedure
Change in average daytime/night-time ambulatory systolic blood pressure between baseline and 3, 6 months post-procedure.	between baseline and 3, 6 months post-procedure.
Change in average daytime/night-time ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure	between baseline and 3, 6 months post-procedure
Change in office (attended) and ambulatory heart rate between baseline and 3, 6 months post-procedure	between baseline and 3, 6 months post-procedure
Changes in dipper/non-dipper patterns between baseline and 3, 6 months post-procedure	between baseline and 3, 6 months post-procedure
Change in retinal arterial remodeling between baseline and 3, 6 months post-procedure	between baseline and 3, 6 months post-procedure
Change in retinal capillary density between baseline and 3, 6 months post-procedure	between baseline and 3, 6 months post-procedure

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 23-388-MDz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes