Assessment of hypertension control and clinical course of patients excluded from the SYMPLICITY HTN-3 trial.

The screening of patients referred for the Symplicity Renal-Denervation Catheter Therapy on Resistant Hypertension (SYMPLICITY HTN-3) trial was rigorous, with many found not eligible to participate. We investigate patients who were not included in the trial and evaluate their current hypertensive (HTN) therapy, control and clinical status. A retrospective review and telephone interview was performed 8-10 months postscreening on 45 patients and their referring providers who were ultimately not included. Patients were grouped into 4 categories: (1) noninterest; (2) excluded (not meeting inclusion criteria); (3) screen failure (excluded during screening visits due to adequate blood pressure control guided by HTN specialist); or (4) referred after enrollment closure. Primary outcomes evaluated included current anti-HTN management and clinical outcomes. This population consisted of 42% males, mean age 65 ± 5 years, 78% African American, 64% diabetic, and 21% chronic kidney disease. Primary referral basis included cardiology (44%), nephrology (30%), and primary care (26%). At time of follow-up, 20% had continued resistant HTN while most of the patients had controlled HTN (60%); with highest success rates among the screen failure group (88%) who also had the lowest average systolic blood pressure (137 ± 11 mm of Hg) when compared to other groups (P = .04). Average number of medications was lowest in the screen failure group (2.8 ± 1.6, P = .07). Resistant and/or uncontrolled HTN was most prevalent in the noninterest or excluded groups, as were hospitalization for cardiovascular and HTN urgency/emergency. This study highlights the disparity of HTN control and treatment in daily practice compared with clinical trials, and confirms a need for vigilant screening of those considered candidates for renal denervation.

RCT Entities:   Population Interventions Outcomes