Renal Denervation in ADPKD- RDN-ADPKD Study (NCT05460169) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Renal Denervation in ADPKD- RDN-ADPKD Study
Germany44 participantsStarted 2022-06-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 interventio…
What they're measuring
1
change in systolic 24-h ambulatory BP [whole study group]
Timeframe: 3 months post-procedure
Trial details
NCT IDNCT05460169
SponsorUniversity of Erlangen-Nürnberg Medical School