Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial

摘要: Summary Background Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect on pressure absence antihypertensive medications. Methods SPYRAL HTN-OFF MED a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres USA, Europe, Japan, and Australia. Eligible patients drug-naive or discontinued their with an office systolic (SBP) 150 mm Hg greater less than 180 Hg, diastolic (DBP) 90 greater, mean 24-h ambulatory SBP 140 170 second screening underwent angiography randomly assigned sham control. Patients, caregivers, those assessing blinded randomisation assignments. primary endpoint, change 3 months, compared between groups. Drug surveillance done ensure patient compliance medication. analysis intention-to-treat population. Safety events assessed months. This is registered ClinicalTrials.gov, number NCT02439749. Findings Between June 25, 2015, Jan 30, 2017, 353 screened. 80 (n=38) control (n=42) followed up for Office decreased significantly from baseline months group: −5·5 (95% CI −9·1 −2·0; p=0·0031), DBP −4·8 (−7·0 −2·6; p Interpretation Results provide biological proof principle blood-pressure-lowering denervation. Funding Medtronic.