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. 2012 May 9;35(9):528–535. doi: 10.1002/clc.22008

Table 1.

Summary of SYMPLICITY HTN‐1 and HTN‐2 Clinical Trials

HTN‐1 [N = 153] HTN‐2 [N = 106]
Trial design Multicenter, prospective, open‐label (pooled analysis of first‐in‐man and phase I studies) Multicenter, open‐label, randomized trial; n = 52 randomized to immediate RDN, n = 54 controls
Patient age (mean ± SD), y 57 ± 11 58 ± 12
No. antihypertensive medications 5.1 ± 1.5 5.2 ± 1.5 (RDN), 5.3 ± 1.8 (control)
Antihypertensive use by class at baseline
 ACE inhibitor/ARB 91% 95%
β‐blocker 82% 75%
 CCB 75% 81%
 Diuretic 95% 89%
Mean baseline blood pressure (mean ± SD), mm Hg 176/98 ± 17/14 178/96 ± 18/16 (RDN), 178/97 ± 17/16 (control)
Reduction in blood pressure −25/−11 (at 6 months; n = 86), −32/−14 (at 24 months; n = 18) −32/−12 (RDN group at 6 months; n = 49),a +1/0 (control group at 6 months; n = 51)

Abbreviations: ACE, angiotensin‐converting enzyme; ARB, angiotensin‐receptor blocker; CCB, calcium channel blocker; RDN, renal denervation; SD = standard deviation.

a

P < 0.0001 for difference between RDN and control systolic and diastolic blood pressure reductions.