Assessment of Early GFR, Tubular Function and Pathology Changes Early and Late After Renal denervatioN

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRede Optimus Hospitalar SA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

Patients in emergency situations

Turbid urine sample on admission

Visible haematuria in the urine sample on admission

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sampling

    Diagnostic test

    Blood samples will be taken to examine the mGFR as parameter for kidney function

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients who will undergo a renal denervation procedure within their standard of careOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline visit (Day 1) and 12 months follow-up visit

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: