A controlled trial of renal denervation for resistant hypertension

Abstract (PubMed)

Prior unblinded studies suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. We designed a prospective, 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. The primary efficacy end point was the change in office systolic blood pressure at 6 months. A total of 535 patients underwent randomization. The mean change in systolic blood pressure at 6 months was -14.13 mmHg in the denervation group versus -11.74 mmHg in the sham-procedure group (difference not statistically significant). Renal denervation was not superior to sham procedure.