Renal Denervation in ADPKD- RDN-ADPKD Study (RDN-ADPKD)
Uncontrolled Hypertension, Autosomal Dominant Polycystic Kidney Disease, Renal Denervation
About this trial
This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring Uncontrolled Hypertension, Autosomal Dominant Polycystic Kidney Disease, Renal denervation
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 < 45ml/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)
Sites / Locations
- University Hospital FAU Erlangen-NürnbergRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Immediate Renal Denervation Group (I-RDN-group)
Delayed Renal Denervation Group (D-RDN-group)
Patients are randomized into (immediate) I-RDN-group and (delayed) D-RDN-group, respectively. All subjects in the I-RDN-group will undergo a diagnostic, renal angiogram immediately (based on clinical grounds to rule out renal artery stenosis), which should be per Institutional practice via femoral artery access. Renal Denervation procedure will be applied using the Paradise® Renal Denervation System. The Paradise® Renal Denervation 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.
3 months after randomization, patients in the (delayed) D-RDN-group will undergo renal denervation procedure after undergoing a diagnostic, renal angiogram and will be followed for additional 36 months.