Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis

NCT06556407 | Recruiting FDA Device

• 1 other identifier: 23-388-MDz
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Hypertension; Chronic Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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.

Study Arms (1)

Treatment

OTHER

Intervention: Renal denervation

Device: renal denervation

Interventions

renal denervation DEVICE

ultrasound based renal denervation

Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension

Erlangen, Bavaria, 91054, Germany

RECRUITING

Central Study Contacts

Agnes Bosch, MD

CONTACT

+49 9131 8536207; agnes.bosch@uk-erlangen.de

Roland E. Schmieder, MD

CONTACT

+499131 8536207; roland.schmieder@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, single-center feasibility study

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 16, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)