| Design |
Open-label, proof of concept |
Prospective, randomized trial |
Prospective, single-blind, randomized, sham-controlled trial |
Prospective, open-label randomized controlled trial with blinded endpoint evaluation in patients with resistant hypertension |
Randomized, single-blind, sham-control trial |
| Subjects |
153 subjects with an elevated office systolic blood pressure (SBP; ≥160 mm Hg) despite taking ≥ 3 antihypertensive drug classes, 1 of which was a diuretic |
106 subjects with a baseline SBP of 160 mm Hg or more despite taking three or more antihypertensive drugs were randomly allocated to renal denervation (n = 52) or control (n = 54) group (maintaining previous medical treatment alone) |
535 patients with severe resistant hypertension underwent randomization in a 2:1 ratio to renal denervation or a sham procedure |
106 subjects with resistant hypertension were randomly assigned in a 1:1 ratio to either renal denervation plus an antihypertensive regimen (renal denervation group) or the same antihypertensive treatment alone (control group) |
331 hypertensive subjects were randomly assigned to either renal denervation (n = 166) or a sham procedure (n = 165) |
| Follow-up |
At 1, 3, 6 12, 18, and 24 months |
Primary endpoint was assessed at 6 months |
6 months |
6 months |
Primary endpoint (baseline-adjusted change in 24-hour SBP) was evaluated at 3 months |
| Mean change in blood pressure (BP) values |
92% of patients had an office BP reduction of ≥ 10 mm Hg |
84% of the patients who underwent renal denervation had a reduction in SBP of 10 mm Hg or more, compared to 35% of controls (p < 0.0001) |
No significant reduction of SBP in patients with resistant hypertension at 6 months after renal-artery denervation when compared with the control group |
Renal denervation plus standardized treatment decreased ambulatory blood pressure more than the same treatment alone |
At 3 months, the mean difference between the two groups for the primary endpoint was −3.9 mm Hg |
