Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial

Aims The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensive patients. The current report describes the effects of RDN on heart rate (HR) in this population. Methods and results Patients were enrolled with an office systolic BP (SBP) of 150mmHg and <180mmHg, office diastolic BP (DBP) of 90mmHg, and a mean ambulatory SBP of 140mmHg and <170mmHg. Patients were drug naive or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P=0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3months for average morning HR (-4.4 b.p.m., P=0.046) and minimum morning HR (-3.0 b.p.m., P=0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7mmHg difference, P=0.001) and DBP (-7.5mmHg, P<0.001), whereas BP changes in RDN patients with below-median HRs were not significant. Conclusion Average and minimum morning HR were significantly reduced at 3months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure.