Effect of Renal Denervation on Blood Pressure in Patients With Chronic Kidney Disease and Uncontrolled Hypertension: Results of a Prospective Randomized Sham-Controlled Study

Objective: The activity of the sympathetic nervous system (SNS) is increased in patients with chronic kidney disease (CKD) and endovascular renal denervation (RDN) offers the opportunity to modulate SNS activity and thereby blood pressure. Hypothesis: In patients with CKD stage 3 and uncontrolled hypertension, endovascular ultrasound-based RDN (uRDN) reduces 24-hour ambulatory BP without adverse safety events. Design and method: In a multicenter prospective randomized clinical trial, following the criteria of a blinded sham-controlled design, patients with CKD stage 3 and uncontrolled hypertension despite prescription of 1-5 antihypertensive medications were enrolled. Patients were randomly allocated to either endovascular uRDN using the Paradise™ Renal Denervation System (ReCor Medical, Inc., Palo Alto, CA, USA) or a sham procedure restricted to renal angiopgraphy alone. The primary endpoint was the change in mean 24-hour ambulatory systolic BP at 6 months while on stable medication. Secondary endpoints were changes of other 24h ambulatory BP values, office BP and safety parameters of uRDN. Blinding was to be maintained through 6 months. Due to slow recruitment through 2 years, the trial was prematurely stopped. Results: Of 25 randomized patients (mean age 67yrs), 20 subjects had a 6 month visit per protocol. Major cause of CKD was hypertension and/or type-2 diabetes (N=13). There was no difference in clinical characteristics (eGFR, UACR, BMI, HbA1c, comorbidities), pretreatment 24 hour/day/night ambulatory and office BP between the uRDN (N=10) and the sham group (N=10). After 6 months the decrease in 24h(and day) ambulatory diastolic BP was significantly greater in the RDN compared with the sham group (p=0.035 (and 0.030)). Within the uRDN group, 24 hour (and day) ambulatory diastolic BP decreased over time compared to pretreatment values, whereas in the sham group no changes occurred. Systolic ambulatory BP decreased numerically in the uRDN group, but was not significant. No safety concerns related to uRDN emerged. Conclusions: In this randomized sham-controlled blinded study, despite its premature stop leading to a small study cohort, we observed a decrease of diastolic BP after endovascular uRDN and no safety signals in these hypertensive patients with CKD.