DOI: 10.1097/hjh.0000000000004482 ISSN: 0263-6352

The effect of renal denervation on blood pressure in patients with chronic kidney disease (RDN-CKD Study): Results of a multicentre, prospective, randomized, sham-controlled and blinded investigator-initiated trial

Roland E. Schmieder, Dennis Kannenkeril, Michael Böhm, Felix Mahfoud, Lars C. Rump, Johannes Stegbauer, Markus van der Giet, Markus R. Meyer, Mario Schiffer, Roland Veelken, Michael Uder, Axel Schmid
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Background:

Endovascular ultrasound renal denervation (uRDN) offers the opportunity to modulate sympathetic nervous system activity, thereby lowering blood pressure (BP) and potentially improving or stabilizing renal outcomes.

Objective:

We hypothesized that in patients with chronic kidney disease (CKD) stage 3 and uncontrolled hypertension, endovascular ultrasound-based RDN will lower BP after 6 months.

Methods:

This multicenter, prospective, randomized, sham-controlled, blinded, clinical trial, investigated the effects of uRDN or sham in patients with CKD stage 3 and uncontrolled hypertension. The primary and secondary endpoints were changes in ambulatory BP (ABP) and office BP at 6 months. The study was prematurely stopped due to slow enrollment.

Results:

Twenty subjects (uRDN: N  = 10, sham: N  = 10) completed the 6-month visit. At 6 months, the sham-corrected change from baseline in 24 h systolic ABP was −5.60 mmHg (95% CI −10.7, −0.54 mmHg; P  = 0.170). The sham corrected change from baseline in 24-h diastolic ABP was −5.90 mmHg (95% CI −9.25, −2.55; P  = 0.035) and from baseline daytime ABP −6.85 mmHg (95% CI −10.6, −3.08; P  = 0.030). Sensitivity analysis restricting the analysis to those patients who were fully adherent to medication ( N  = 7 in each group) found a sham-corrected change from baseline 24-h diastolic ABP of −5.71 mmHg (95% CI −9.40, −2.03; P  = 0.053) at 6 months. Based on the composite endpoint of 24 h ABP and office BP for systolic/diastolic BP, a win ratio of 1.71 (95% 1.26–2.34; P  = 0.014) was found for systolic BP and a win ratio of 4.59 (95% CI 2.94–7.16, P  < 0.001) was found for diastolic BP, indicating significant changes in BP following RDN. Estimated glomerular filtration rate remained stable over 6 months, with no difference between the groups. There were no safety signals associated with uRDN.

Conclusions:

This prospective randomized, sham controlled, blinded trial in patients with uncontrolled hypertension and CKD was prematurely stopped, resulted in small number of patients and we did not find a statistically significant effect on systolic BP, whereas a consistent reduction in diastolic BP following uRDN was observed. These data should guide the design of a larger confirmatory trial in patients with CKD.

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