Renal denervation: The Paradise® Renal Denervation System (Paradise System) is CE-marked in countries accepting the CE mark. The system is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.
Study summary
RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-center, hypothesis-generating, feasibility study. The purpose of the RDN-ADPKD study is to demonstrate efficacy and document safety of renal denervation (RDN) with the Paradise System in hypertensive patients with ADPKD.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with ADPKD
* Systolic office (attended) BP ≥130 mmHg or diastolic office (attended) BP ≥80 mmHg confirmed by 24-h ambulatory BP systolic ≥125 mmHg or diastolic ≥75 mmHg despite treatment with 1-4 drug classes (RAS blockade is mandatory, unless intolerance to RAS blockers has been documented) The rationale of these inclusion criteria reflect the November 2021 updated knowledge of RDN according to international consensus reports, in particular in face of conducting clinic studies and randomized controlled trials and does not necessarily reflect the current application of RDN in clinical practice). Moreover, the most recent updated KDIGO guidelines recommend a target office BP \< 120 mmHg in patients with chronic kidney disease.1.
* Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks
* Individual is ≥ 18 years of age, both genders are included
Exclusion Criteria:
* eGFR \< 40ml/min/1.73m² (according to the currently used estimation formulas: MDRD (Modification of Diet in Renal Disease), CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration))
* Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement
* Prior renal denervation procedure
* Office (attended) BP ≥180 mmHg systolic and/or ≥110 mmHg diastolic
* 24-h ambulatory BP ≥160 mmHg systolic
* Other cause of hypertension that can be treated by intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma)
* Type 1 diabetes mellitus
* Proteinuria (\>3g/g Kreatinin)
* Contraindication to MRI
* Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit
* 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)
Primary outcome measure(s)
change in systolic 24-h ambulatory BP [whole study group] — 3 months post-procedure change in systolic 24-h ambulatory BP at 3 months post-procedure from pre-treatment in the whole study group (irrespective whether treated immediate \[I-RDN-group\] or delayed \[D-RDN-group\]).
Trial sites (1)
Facility
City
Region
Status
University Hospital FAU Erlangen-Nürnberg
Erlangen
Germany
More University of Erlangen-Nürnberg Medical School trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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