Renal Denervation Therapy
Conditions
Brief 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 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.
Interventions
DIAGNOSTIC_TESTblood sampling
Blood samples will be taken to examine the mGFR as parameter for kidney function
Sponsors
Rede Optimus Hospitalar SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit | 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. |
Contacts
CONTACTAlexandra Greindl, Dr
Outcome results
None listed