- Question
- Does endovascular ultrasound renal denervation lower ambulatory blood pressure in patients with hypertension who are off antihypertensive medications?
- Design
- Multicentre, international, single-blind, 1:1 randomised, sham-controlled trial conducted at 21 centres in the USA and 18 in Europe. A total of 146 patients were randomised; the primary endpoint was assessed at 2 months of follow-up.
- Population
- Adults aged 18 to 75 years with combined systolic-diastolic hypertension, ambulatory blood pressure ≥135/85 and <170/105 mm Hg after a 4-week washout of up to two antihypertensive drugs, and suitable renal artery anatomy.
- Intervention
- Renal denervation with endovascular ultrasound using the Paradise system (ReCor Medical), with patients remaining off antihypertensive medication during follow-up unless prespecified blood pressure thresholds were exceeded.
- Control
- A sham procedure consisting of renal angiography only.
- Primary outcome
- Change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population.
- Results
- The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (−8.5 mm Hg, SD 9.3) than with the sham procedure (−2.2 mm Hg, SD 10.0); baseline-adjusted between-group difference was −6.3 mm Hg (95% CI −9.4 to −3.1; p=0.0001).
- Safety
- No major adverse events were reported in either group.
- Conclusion
- Compared with a sham procedure, ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with hypertension off medications.
- Why it matters
- It provided sham-controlled evidence that ultrasound renal denervation lowers blood pressure independently of drug therapy, strengthening its role as a therapeutic option in 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 14, 2026