- Question
- Does catheter-based renal-artery denervation lower blood pressure in patients with resistant hypertension compared with a sham procedure?
- Design
- Prospective, single-blind, randomized (2:1), sham-controlled trial with 535 randomized patients; funded by Medtronic.
- Population
- Patients with severe resistant hypertension on a stable antihypertensive regimen of at least three drugs, including a diuretic, at maximally tolerated doses.
- Intervention
- Catheter-based renal-artery denervation, with baseline antihypertensive medications maintained.
- Control
- A sham procedure consisting of renal angiography, with baseline antihypertensive medications maintained.
- Primary outcome
- Change in office systolic blood pressure at 6 months; the primary safety end point was a composite of death, end-stage renal disease, embolic events with end-organ damage, renovascular complications, or hypertensive crisis at 1 month, or new renal-artery stenosis of more than 70% at 6 months.
- Results
- Office systolic blood pressure fell by 14.13 ± 23.93 mm Hg with denervation and 11.74 ± 25.94 mm Hg with sham, a difference of -2.39 mm Hg (95% CI, -6.89 to 2.12; P=0.26 for superiority with a 5 mm Hg margin). For 24-hour ambulatory systolic pressure the difference was -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a 2 mm Hg margin).
- Safety
- There were no significant differences in safety between the two groups.
- Conclusion
- Renal denervation did not produce a significant reduction in systolic blood pressure at 6 months compared with a sham procedure in resistant hypertension.
- Why it matters
- This neutral result contradicted earlier unblinded studies and underscored the importance of sham controls in device trials; it tempered early enthusiasm for renal denervation and prompted a redesign of subsequent research on the technique.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026