Assessment of Early GFR, Tubular Function and Pathology Changes Early and Late After Renal denervatioN (AEGEAN)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra Greindl, Dr
- Phone Number: +49 157 851 281 40
- Email: alexandra.greindl@redeoptimus.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients who will undergo a renal denervation procedure within their standard of care
bio sample collection (blood, urine)
|
Blood samples will be taken to examine the mGFR as parameter for kidney function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline visit (Day 1) and 12 months follow-up visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RO-250206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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