SPYRAL HTN-OFF MED TRIAL

Abstract

Objective: Heart rate (HR) is associated with cardiovascular outcomes in hypertensive high-risk vascular patients and heart failure. Recently, the randomized, sham-controlled SPYRAL HTN-OFF MED trial showed reduction of office and ambulatory blood pressure (BP) at 3 months post-renal denervation. The objective of the current analysis is to evaluate the effect of renal denervation on HR in an uncontrolled hypertensive population without medication. Design and method: The SPYRAL HTN-OFF MED trial enrolled uncontrolled hypertensive patients who were drug naïve or removed from their antihypertensive medications. Patients were randomized 1:1 to renal denervation or sham control procedure. BP and HR were measured at baseline and 3 months post-procedure using ambulatory BP monitoring and in the office. For office BP and HR, each data point was an average of 3 measurements. Post-hoc analyses compared changes at 3 months in BP and HR for patients with baseline office HR above and below the median. Results: At 3 months, average office, 24-hour, daytime and night-time HR were significantly reduced in the renal denervation group but not in the sham control group (Table 1). Also, the change in 24-hour HR at 3 months was significantly different between groups. Three-month changes in 24-hour systolic BP, diastolic BP and HR were significantly lower for renal denervation patients with higher baseline HR compared to those with lower baseline HR (Table 2). Similar trends were not seen in the sham control group.Conclusions: In the SPYRAL HTN-OFF MED trial, significant reductions in HR were seen at 3 months in the renal denervation group but not in the sham control group. Post-hoc analyses suggest patients with higher baseline HR could experience greater reductions in ambulatory HR and BP post-renal denervation.