- Question
- Does ultrasound renal denervation lower blood pressure in patients with mild to moderate hypertension, without the confounding effect of antihypertensive medications?
- Design
- Randomized 2:1, sham-controlled clinical trial with patients and outcome assessors blinded to treatment assignment. It was conducted at 37 centers in the US and 24 in Europe between January 2019 and March 2022, with randomization stratified by center.
- Population
- Adults aged 18 to 75 years with hypertension (office systolic BP ≥140 mm Hg and diastolic BP ≥90 mm Hg on up to 2 antihypertensive drugs). After a 4-week medication washout they needed ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg, an estimated glomerular filtration rate ≥40 mL/min/1.73 m2, and suitable renal artery anatomy.
- Intervention
- Endovascular ultrasound renal denervation (Paradise system). Patients were to avoid antihypertensive medications until the 2-month visit unless prespecified BP criteria were exceeded with clinical symptoms.
- Control
- A sham procedure consisting of renal angiography without denervation.
- Primary outcome
- Mean change in daytime ambulatory systolic BP at 2 months. The primary safety outcome was a composite of major adverse events (death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular and hypertensive events at 30 days, and renal artery stenosis >70% at 6 months).
- Results
- A total of 150 patients were randomized to denervation and 74 to sham. Daytime ambulatory systolic BP fell by -7.9 mm Hg with denervation vs -1.8 mm Hg with sham (baseline-adjusted difference -6.3 mm Hg; 95% CI -9.3 to -3.2; P < .001). Of 7 secondary BP outcomes, 6 were significantly improved with denervation.
- Safety
- No major adverse events were reported in either group.
- Conclusion
- In hypertensive patients off antihypertensive medications, ultrasound renal denervation reduced daytime ambulatory systolic BP at 2 months compared with a sham procedure, without postprocedural major adverse events.
- Why it matters
- It provided evidence of the efficacy and safety of ultrasound renal denervation in a medication-free setting, supporting its role as an additional treatment option for 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