Rationale and Design of Sympathetic Mapping/Ablation of Renal Nerves Trial (SMART) for the Treatment of Hypertension: a Prospective, Multicenter, Single-Blind, Randomized and Sham Procedure-Controlled Study

Abstract

Renal denervation (RDN) is proposed as a durable and patient compliance independent treatment for hypertension. However, 20-30% non-responder after RDN treatment weakened the therapeutic effect, which may be due to blind ablation. The renal nerve mapping/selective ablation system developed by SyMap Medical Ltd (Suzhou), China, has the function of mapping renal sympathetic/parasympathetic nerve sites and selectively removing renal sympathetic nerves and is expected to meet the urgent unmet clinical need of targeted RDN. The "Sympathetic Mapping/Ablation of Renal Nerves Trial" (SMART) is a prospective, multicenter, randomized, single-blinded, sham procedure-controlled trial, to evaluate the safety and efficacy of targeted renal sympathetic denervation in patients with essential and uncontrolled hypertension. The study is the first clinical registry trial using a targeted RDN for the treatment of uncontrolled hypertension; the dual-endpoint design can answer the question of how many antihypertensive drugs can be reduced in patients after RDN. The trial is registered on clinicaltrials.gov NCT02761811.

Keywords: Hypertension; Renal denervation; Renal nerve mapping; Selective ablation; Study design.