Efficacy of ultrasound renal denervation adjusted for changes in detected antihypertensive medications in the RADIANCE-HTN TRIO Study

Endovascular ultrasound renal sympathetic denervation (uRDN) was demonstrated to lower daytime ambulatory systolic blood pressure (dASBP) by 5.9 mmHg as compared to a sham procedure at 2 months123. The blood pressure (BP)-lowering effect of uRDN may have been confounded by uncontrolled and non-protocol-defined changes in concomitant antihypertensive medications (AHMs). These changes could have resulted from either patient non-adherence to protocol-defined AHMs or physician prescriptions that deviated from the study protocol. The aim of the current analysis was to evaluate the BP-lowering effect of uRDN adjusted for changes in detected AHMs. The RADIANCE-HTN TRIO trial was an international multicentre randomised sham-controlled trial in patients with resistant hypertension (RH; ClinicalTrials.gov: NCT02649426)24. After 4 weeks of standardised therapy (valsartan/olmesartan, amlodipine and hydrochlorothiazide), patients with daytime ambulatory BP ≥135/85 mmHg were randomised to uRDN with the Paradise Ultrasound Renal Denervation system (Recor Medical) or a sham procedure. Ambulatory BP monitoring coinciding with urine chemical adherence testing for the detection of AHMs or their metabolites (using ultra-high performance liquid chromatography coupled with tandem mass spectrometry [LC-MS/MS]) was performed at baseline,...