Clevidipine in acute heart failure: Results of the A Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO)

W. Frank Peacock, Abhinav Chandra, Douglas Char, Sean Collins, Guillaume Der Sahakian, Li Ding, Lala Dunbar, Gregory Fermann, Gregg C. Fonarow, Norman Garrison, Ming Yi Hu, Patrick Jourdain, Said Laribi, Phillip Levy, Martin Möckel, Christian Mueller, Patrick Ray, Adam Singer, Hector Ventura, Mason WeissAlex Mebazaa

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52 Scopus citations

Abstract

Background Rapid blood pressure (BP) control improves dyspnea in hypertensive acute heart failure (AHF). Although effective antihypertensives, calcium-channel blockers are poorly studied in AHF. Clevidipine is a rapidly acting, arterial selective intravenous calcium-channel blocker. Our purpose was to determine the efficacy and safety of clevidipine vs standard-of-care intravenous antihypertensive therapy (SOC) in hypertensive AHF. Methods This is a randomized, open-label, active control study of clevidipine vs SOC in emergency department patients with AHF having systolic BP ≥160 mm Hg and dyspnea ≥50 on a 100-mm visual analog scale (VAS). Coprimary end points were median time to, and percent attaining, a systolic BP within a prespecified target BP range (TBPR) at 30 minutes. Dyspnea reduction was the main secondary end point. Results Of 104 patients (mean [SD] age 61 [14.9] years, 52% female, 80% African American), 51 received clevidipine and 53 received SOC. Baseline mean (SD) systolic BP and VAS dyspnea were 186.5 (23.4) mm Hg and 64.8 (19.6) mm. More clevidipine patients (71%) reached TBPR than did those receiving SOC (37%; P =.002), and clevidipine was faster to TBPR (P =.0006). At 45 minutes, clevidipine patients had greater mean (SD) VAS dyspnea improvement than did SOC patients (-37 [20.9] vs -28 mm [21.7], P =.02), a difference that remained significant up to 3 hours. Serious adverse events (24% vs 19%) and 30-day mortality (3 vs 2) were similar between clevedipine and SOC, respectively, and there were no deaths during study drug administration. Conclusions In hypertensive AHF, clevidipine safely and rapidly reduces BP and improves dyspnea more effectively than SOC.

Original languageEnglish
Pages (from-to)529-536
Number of pages8
JournalAmerican heart journal
Volume167
Issue number4
DOIs
StatePublished - Apr 2014

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    Peacock, W. F., Chandra, A., Char, D., Collins, S., Der Sahakian, G., Ding, L., Dunbar, L., Fermann, G., Fonarow, G. C., Garrison, N., Hu, M. Y., Jourdain, P., Laribi, S., Levy, P., Möckel, M., Mueller, C., Ray, P., Singer, A., Ventura, H., ... Mebazaa, A. (2014). Clevidipine in acute heart failure: Results of the A Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO). American heart journal, 167(4), 529-536. https://doi.org/10.1016/j.ahj.2013.12.023