Renal Denervation TherapyAEGEANNCT07786636
Assessment of Early GFR, Tubular Function and Pathology Changes Early and Late After Renal denervatioN
A study testing blood sampling in people with Renal Denervation Therapy, run by Rede Optimus Hospitalar SA.
Trial summary
The purpose of this clinical study is to better understand how renal denervation (RDN) affects kidney function, both shortly after and up to a year after the procedure. Renal denervation is a minimally invasive treatment used for patients with high blood pressure that does not respond well to medication ("resistant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Denervation Therapy
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- eGFR >30 ml/min/1.73m2 (CKD stages 3b and less severe)
- Informed consent for study participation provided by the patient or the legal guardian
- Patient information and consent to the processing of personal data
- Stable therapy in the previous three months
- All patients undergoing RDN for clinical indications
Who cannot join
- Patients in emergency situations
- Turbid urine sample on admission
- Visible haematuria in the urine sample on admission
- Pregnancy
- Allergy to contrast media (visipaque, omnipaque, iohexol)
- Any problem, which, in the investigator's opinion, might jeopardize the participant's compliance with the protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this clinical study is to better understand how renal denervation (RDN) affects kidney function, both shortly after and up to a year after the procedure. Renal denervation is a minimally invasive treatment used for patients with high blood pressure that does not respond well to medication ("resistant hypertension"). It works by reducing the activity of nerves that run along the arteries supplying the kidneys, which helps lower blood pressure.
To understand how RDN affects the kidneys, we will measure kidney function in detail and analyse blood and urine samples collected before and after the procedure. This will help researchers see whether the procedure causes changes in the kidneys, and whether some of these changes are linked to better kidney health over time.
- Conditions
- Renal Denervation Therapy
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
Blood samples will be taken to examine the mGFR as parameter for kidney function
| Study group | Role | What they receive |
|---|---|---|
| Patients who will undergo a renal denervation procedure within their standard of care | Other | bio sample collection (blood, urine) Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit
Change of a specific protein score in urine prior to standard of care index procedure and 12 months from index procedure.
Samples will be stored until the last patient had the last visit. All measurements will be then done afterwards.
Measured: Baseline visit (Day 1) and 12 months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Denervation TherapyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rede Optimus Hospitalar SA
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786636
- Sponsor's protocol ID
- RO-250206
- Acronym
- AEGEAN
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early GFR, Tubular Function and Pathology Changes Early and Late After Renal denervatioN
- ClinicalTrials.gov ID
- NCT07786636
- Acronym / sponsor ID
- AEGEAN / RO-250206
- Conditions
- Renal Denervation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rede Optimus Hospitalar SAResearch network
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 26 Aug 2026 (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 purpose of this clinical study is to better understand how renal denervation (RDN) affects kidney function, both shortly after and up to a year after the procedure. Renal denervation is a minimally invasive treatment used for patients with high blood pressure that does not respond well to medication ("resistant hypertension"). It works by reducing the activity of nerves that run along the arteries supplying the kidneys, which helps lower blood pressure.
To understand how RDN affects the kidneys, we will measure kidney function in detail and analyse blood and urine samples collected before and after the procedure. This will help researchers see whether the procedure causes changes in the kidneys, and whether some of these changes are linked to better kidney health over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who will undergo a renal denervation procedure within their standard of care | Other | Diagnostic Test: blood samplingbio sample collection (blood, urine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years
- eGFR >30 ml/min/1.73m2 (CKD stages 3b and less severe)
- Informed consent for study participation provided by the patient or the legal guardian
- Patient information and consent to the processing of personal data
- Stable therapy in the previous three months
Key exclusion criteria (6 listed)
- Patients in emergency situations
- Turbid urine sample on admission
- Visible haematuria in the urine sample on admission
- Pregnancy
- Allergy to contrast media (visipaque, omnipaque, iohexol)
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 |
|---|---|---|
| blood samplingBlood samples will be taken to examine the mGFR as parameter for kidney function | Diagnostic test | Patients who will undergo a renal denervation procedure within their standard of care |
Primary outcome
Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit
Time frame: Baseline visit (Day 1) and 12 months follow-up visit
Change of a specific protein score in urine prior to standard of care index procedure and 12 months from index procedure. Samples will be stored until the last patient had the last visit. All measurements will be then done afterwards.
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 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Renal Denervation Therapy
Recruiting
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Hypertension, Vascular Diseases
Not yet recruiting
The RESPLASH Study
Resistant Hypertension
Recruiting
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
Hypertension
Active, not recruiting
A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension
Resistant Hypertension
Recruiting
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
Resistant Hypertension
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.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Renal Denervation Therapy, run by Rede Optimus Hospitalar SA.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Alexandra Greindl, Dr (+49 157 851 281 40, alexandra.greindl@redeoptimus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit (time frame: Baseline visit (Day 1) and 12 months follow-up visit). 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 Aug 2026.