12-Months Follow-Up Data From the RDN-CKD Study: Blood Pressure Reduction and Renal Function Following Ultrasound Renal Denervation in Patients With Chronic Kidney Disease Stage 3

Objective: Renal denervation (RDN) is considered as a therapeutic option to treat the increased sympathetic nervous system activity in patients with chronic kidney disease (CKD). In a prospective, randomized, sham-controlled, double-blinded clinical trial (RDN-CKD study; ClinicalTrials.gov: NCT04264403), we observed a reduction in diastolic blood pressure in hypertensive patients with stage 3 CKD six months after ultrasound renal denervation (uRDN). We now evaluated blood pressure reduction 12-months after uRDN. Design and method: 12-month follow-up data were available for 15 patients (8 patients receiving uRDN immediately and 7 patients receiving uRDN after cross-over) from the centers Erlangen and Nuremberg with CKD stage 3 and uncontrolled hypertension, having undergone uRDN (with the PARADISE System, ReCor Medical Inc., USA) despite treatment with 1–5 antihypertensive agents. Office and 24-hour ambulatory BP as well as renal function were assessed 12 months after uRDN. Results: The mean age of the patients with CKD (baseline eGFR 50.5±12.2 mL/min/1.73m2) was 66.0±10.2 years. Twelve months after uRDN, 24-hour systolic and diastolic ambulatory BP decreased by 8.7±12.7mmHg (p=0.018) and 6.5±9.3mmHg (p=0.016), respectively (Table 1). Office BP measurements showed significant reduction, with mean systolic BP reduced by 11.9±16.4mmHg (p=0.011) and diastolic BP by 7.3±7.9mmHg (p=0.002). No significant changes were observed in both the number and dosage of prescribed antihypertensive medications throughout the study period. Renal function remained stable with a mean eGFR of 47.5±10.3 mL/min/1.73m2 at 12 months compared to baseline (p=0.114). No significant reduction was observed with urinary albumin creatinine ratio. The blood pressure reduction was not different between CKD group 3a and 3b. No safety concerns related to uRDN were identified at the 12-month follow up.Conclusions: Significant reductions in both systolic and diastolic blood pressure were observed at 12 months following uRDN in patients with stage 3 CKD and uncontrolled hypertension. Given the sustained BP reduction and stable renal function, uRDN may represent a promising adjunctive approach for managing uncontrolled hypertension in patients with moderate CKD.