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

September 22, 2025 updated by: University of Erlangen-Nürnberg Medical School

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Treatment
Intervention: Renal denervation
Device: renal denervation
ultrasound based renal denervation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety endpoints and adverse effects
Time Frame: during 6 months post-procedure
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
Time Frame: baseline and 3 months post-procedure
baseline and 3 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: between baseline and 3, 6 months post-procedure
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
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: between baseline and 3, 6 months post-procedure
between baseline and 3, 6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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