Treatment Resistant HypertensionRDN-HDNCT06556407
Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
A study testing renal denervation in people with Treatment Resistant Hypertension and Chronic Hemodialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Treatment Resistant Hypertension, Chronic Hemodialysis
- What is being tested?
- renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 4 Mar 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension
Erlangen, Bavaria, 91054
Agnes Bosch, MD, +49 9131 8536216, agnes.bosch@uk-erlangen.de
About this study
Official title: 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.
Read the 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
- Being tested
- renal denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal denervationDevice
ultrasound based renal denervation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Intervention: Renal denervation Receives: Device: renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints and adverse effects
A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU
Measured: during 6 months post-procedure
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure
Measured: baseline and 3 months post-procedure
Secondary outcomes (14)
Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure
Measured: between baseline and 6 months post-procedure.
Change in 24-h ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure
Measured: baseline and 3, 6 months post-procedure.
Change in office (attended) systolic and diastolic blood pressure between baseline and 3, 6 months post-procedure
Measured: between baseline and 3, 6 months post-procedure
Change in systolic and diastolic home blood pressure between baseline and 3, 6 months post-procedure.
Measured: between baseline and 3, 6 months post-procedure
Number of antihypertensive drugs, doses, classes at 3, 6 months post-procedure compared to baseline.
Measured: 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.
Measured: 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
Measured: between baseline and 3,6 months post procedure
Change in retinal arteriolar wall to lumen ratio between baseline and 3,6 months post procedure
Measured: 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.
Measured: 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
Measured: between baseline and 3, 6 months post-procedure
Change in office (attended) and ambulatory heart rate between baseline and 3, 6 months post-procedure
Measured: between baseline and 3, 6 months post-procedure
Changes in dipper/non-dipper patterns between baseline and 3, 6 months post-procedure
Measured: between baseline and 3, 6 months post-procedure
Change in retinal arterial remodeling between baseline and 3, 6 months post-procedure
Measured: between baseline and 3, 6 months post-procedure
Change in retinal capillary density between baseline and 3, 6 months post-procedure
Measured: between baseline and 3, 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start4 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single-center feasibility study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556407
- Sponsor's protocol ID
- 23-388-MDz
- Acronym
- RDN-HD
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Renal Denervation on Blood Pressure in Patients With Treatment Resistant Hypertension, End-stage Chronic Kidney Disease and Hemodialysis
- ClinicalTrials.gov ID
- NCT06556407
- Acronym / sponsor ID
- RDN-HD / 23-388-MDz
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single-center feasibility study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: renal denervationIntervention: Renal denervation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal denervationultrasound based renal denervation | Device | Treatment |
Primary outcome
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
Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure
Time frame: baseline and 3 months post-procedure
14 secondary outcomes
Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure
Time frame: 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.
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
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
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.
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
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
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
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.
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
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
Changes in dipper/non-dipper patterns between baseline and 3, 6 months post-procedure
Time frame: 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
Change in retinal capillary density between baseline and 3, 6 months post-procedure
Time frame: between baseline and 3, 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal denervation in people with Treatment Resistant Hypertension and Chronic Hemodialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnes Bosch, MD (+49 9131 8536207, agnes.bosch@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoints and adverse effects (time frame: during 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.