Renal Denervation in ADPKD- RDN-ADPKD Study

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Jul 11, 2022

Keywords

ClinConnect Summary

The RDN-ADPKD study is looking at a treatment called renal denervation, which is being tested for patients with uncontrolled high blood pressure and a condition known as Autosomal Dominant Polycystic Kidney Disease (ADPKD). This study aims to see if this treatment can help lower blood pressure safely in these patients. To participate, individuals must be at least 18 years old, have ADPKD, and have high blood pressure that hasn't been controlled with medication. They should also be following a stable medication routine for at least four weeks.

Participants in this study can expect to receive either the renal denervation treatment or standard care, and they will be monitored closely throughout the process. It's important to note that certain health conditions, like severe kidney issues or recent heart problems, may prevent someone from joining the study. If you're interested in learning more or think you might qualify, it's a great idea to talk to your healthcare provider.

Gender

ALL

Eligibility criteria

• 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)