Effect of ultrasound renal denervation after crossover from sham in RADIANCE-HTN SOLO

June 25, 2020

Control of hypertension represents an unmet need globally, and RDN is an "adherence-independent" adjunctive therapy to medications. The RADIANCE-HTN SOLO trial was a multicenter randomized controlled trial that demonstrated the blood pressure lowering effect of endovascular ultrasound-based renal denervation compared with a sham control.

We analyzed ambulatory BP and safety data from 31 patients from the sham arm of the RADIANCE-HTN SOLO trial who crossed over and received renal denervation due to elevated ambulatory blood pressures after 12 months of observation. Within this cohort, daytime ambulatory systolic BP dropped following renal denervation by 11.2 mm Hg at 2 months and 12.2 mm Hg at 6 months (p<0.001 in comparison to baseline at time of crossover for both) without an increase in medication burden. There were no major adverse events through 6 months of follow-up after crossover.

These results are consistent with the primary RADIANCE-HTN SOLO results demonstrating the blood pressure lowering effect of ultrasound-based renal denervation. Notably, crossover subjects and physicians were unblinded, so these data are subject to behavioral and/or medication-related effects. Nonetheless, these results may provide some added insights into early procedural efficacy and durability after renal denervation.
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