Methods:

SYMPLICITY HTN-3 was a single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. All patients were on a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic, prior to randomization. The primary efficacy endpoint was the change in office systolic blood pressure at 6 months, and a secondary efficacy endpoint was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety endpoint was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of >70% at 6 months.