Key result
Endovascular ultrasound renal denervation did not significantly reduce 24-h systolic ABP at 6 months (-5.60 mmHg; P=0.170), but significantly reduced 24-h diastolic ABP (-5.90 mmHg; P=0.035).
Why the study?
Endovascular ultrasound renal denervation modulates sympathetic nervous system activity, offering a potential means to lower BP and improve or stabilize renal outcomes in patients with CKD stage 3 and uncontrolled hypertension.
Does endovascular ultrasound-based renal denervation lower blood pressure at 6 months compared to a sham procedure in patients with chronic kidney disease stage 3 and uncontrolled hypertension?
RCT (n=20)
Blinded, sham-controlled
Randomized
Yes
Does endovascular ultrasound-based renal denervation lower blood pressure at 6 months compared to a sham procedure in patients with chronic kidney disease stage 3 and uncontrolled hypertension?
In a small, prematurely terminated trial of patients with stage 3 CKD and uncontrolled hypertension, ultrasound renal denervation was safe and significantly reduced 24-hour diastolic blood pressure, though the reduction in 24-hour systolic blood pressure did not reach statistical significance.
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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Schmieder et al. (2026) conducted an RCT in Chronic kidney disease stage 3 and uncontrolled hypertension (n=20). Endovascular ultrasound renal denervation (uRDN) vs. Sham procedure was evaluated on Changes in ambulatory blood pressure (ABP) and office blood pressure at 6 months (24-h systolic ABP reported first) (MD -5.60 mmHg, 95% CI -10.7 to -0.54, p=0.170). Endovascular ultrasound renal denervation did not significantly reduce 24-h systolic ABP at 6 months (-5.60 mmHg; P=0.170), but significantly reduced 24-h diastolic ABP (-5.90 mmHg; P=0.035).
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