Renal Denervation in Chronic Kidney Disease - RDN-CKD Study (NCT04264403) | Clinical Trial Compass
CompletedNot Applicable
Renal Denervation in Chronic Kidney Disease - RDN-CKD Study
Germany44 participantsStarted 2020-01-23
Plain-language summary
RDN-CKD Study is a prospective, randomized (1:1, central randomization), double-blind (unblinded interventionalist and blinded study team at each center), sham controlled, multicenter feasibility study. The purpose of the RDN-CKD Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 80 patients with chronic kidney disease (CKD) stage 3a or 3b.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* CKD stage 3 (eGFR 30-59 ml/min/1.73m² \[according to the currently used estimation formulas: MDRD, CKD-EPI\]) with diabetic or non-diabetic nephropathy
* Uncontrolled hypertension with 1-5 drug classes (renin angiotensin system \[RAS\] blockade is mandatory, unless intolerance to RAS blockers has been documented) and systolic office (attended) BP ≥140 mmHg confirmed by 24-h ambulatory BP systolic ≥130 mmHg
* Patient is adhering to a stable drug regimen including RAS blockade without changes for a minimum of 4 weeks.
* Individual is ≥ 18 years of age, both genders are included.
Exclusion Criteria:
* Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter Placement
* Other cause of Hypertension that can be treated by Intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma)
* Prior renal denervation procedure
* Office (attended) BP ≥ 180 mmHg systolic and/or ≥ 110 mmHg diastolic
* 24-h ambulatory BP ≥ 160 mmHg systolic
* Anatomic or functional solitary kidney, kidney transplantation
* Lack of capturing serum creatinine levels in the past
* Secondary hypertension other than obstructive sleep apnea
* Type 1 diabetes mellitus
* Nephrotic syndrome
* Contraindication to magnetic resonance imaging (MRI)
* Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 m…
What they're measuring
1
change in systolic 24-h ambulatory BP
Timeframe: at 6 month post-procedure
Trial details
NCT IDNCT04264403
SponsorUniversity of Erlangen-Nürnberg Medical School