- Question
- Does catheter-based renal denervation lower blood pressure compared with a sham procedure in patients with uncontrolled hypertension who remain on antihypertensive drugs, with drug adherence testing?
- Design
- International, randomised, single-blind, sham-controlled proof-of-concept trial at 25 centres in the USA, Germany, Japan, UK, Australia, Austria and Greece. This analysis covers the first 80 randomised patients (38 to renal denervation, 42 to sham), analysed by intention to treat with 6 months of follow-up.
- Population
- Adults aged 20-80 years with uncontrolled hypertension: office systolic BP 150-180 mm Hg, office diastolic BP of 90 mm Hg or higher and 24 h ambulatory systolic BP 140-170 mm Hg, on one to three antihypertensive drugs at stable doses for at least 6 weeks.
- Intervention
- Renal angiography followed by renal denervation in the main renal arteries and branches.
- Control
- Renal angiography alone (sham procedure), with patients, caregivers and blood pressure assessors masked.
- Primary outcome
- Change in blood pressure from baseline, measured by ambulatory monitoring at 6 months, compared between treatment groups.
- Results
- At 6 months, 24 h systolic BP fell more with renal denervation than with sham (difference -7.4 mm Hg; 95% CI -12.5 to -2.3; p=0.0051). Office systolic BP was also lower (difference -6.8 mm Hg; 95% CI -12.5 to -1.1; p=0.0205). At 3 months, reductions did not differ significantly between groups.
- Safety
- No major adverse events were recorded in either group. Medication adherence was about 60% and varied between patients throughout the study.
- Conclusion
- Renal denervation significantly reduced blood pressure versus sham, with no major safety events, in patients on antihypertensive medication.
- Why it matters
- It provided sham-controlled evidence that renal denervation lowers blood pressure even on background medication with verified adherence, renewing interest in it as an adjunctive option for uncontrolled hypertension.
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 18, 2026