R esistant hypertension is defined as a blood pressure (BP) of ≥140/90 mm Hg despite the intake of ≥3 antihypertensive drugs, including a diuretic at maximally tolerated doses. 1 Its prevalence has been reported to be 12.8% in a US population.2 Sympathetic overactivity contributes to the development and perpetuation in a subset of patients with resistant hypertension.3 Its negative effects include sodium and water retention, increased renin release, and alterations of renal blood flow. 3Afferent and efferent sympathetic nerves that travel in the renal artery walls mediate pathological interactions between the central nervous system and the kidneys. Recently, catheterbased disruption of these renal sympathetic nerve fibers using radiofrequency energy has been introduced as a new treatment against resistant hypertension. Initial nonrandomized and randomized, nonblinded trials demonstrated a dramatic reduction in systolic and diastolic BP after renal sympathetic denervation (RSD). 4,5 In contrast, in the recent sham-controlled Simplicity HTN-3 trial of patients with severe treatment-resistant hypertension, RSD led to no significant improvement in BP when compared with the sham group.6 Some think that the results of this trial with the so far most rigorous design commenced the beginning of the end of RSD for resistant hypertension. Proponents of RSD argue that the negative outcome is a consequence of inefficient denervation procedures and suboptimal selection of patients. One aspect that deserves further consideration is that patients recruited into the Simplicity HTN-3 study might represent a population at the most advanced spectrum of the disease with marked and in many cases long-standing hypertension. One could argue that in such patients, RSD might be less effective because of irreversible alterations of the anatomic structures and physiological processes supporting chronic BP elevations. The present trial was conducted to test the hypothesis that RSD is superior to a sham intervention in patients with only mild resistant arterial hypertension. Methods Design OverviewThe trial's main objective was to study a possible blood-pressure lowering effect of RSD in patients with resistant hypertension and mildly elevated BP. Eligible patients between 18 and 75 years of age were randomized to RSD or a sham procedure. Resistant hypertension with mildly elevated BP was defined as (1) a stable antihypertensive drug Abstract-Few data are available with regard to the effectiveness of renal sympathetic denervation in patients with resistant hypertension yet only mildly elevated blood pressure (BP). Patients with resistant hypertension and slightly elevated BP (day-time systolic pressure, 135-149 and diastolic pressure, 90-94 mm Hg on 24-hour ambulatory measurement) were randomized in a 1:1 ratio to renal sympathetic denervation with the Symplicity Flex Catheter (Medtronic) or an invasive sham procedure. The primary efficacy end point was the change in 24-hour systolic BP at 6 months between groups in the intention to treat po...

Exercise systolic BP values in patients with mild therapy-resistant hypertension are reduced after RSD as compared to a sham-procedure.