Abstract 15606: Clevidipine Improves Dyspnea in Emergency Department Acute Heart Failure: A Randomized, Open Label Study
Purpose: Dyspnea from hypertensive acute heart failure (AHF) may improve rapidly with BP reduction. Clevidipine (CLV), a short acting arteriospecific calcium antagonist may be effective in this cohort. Our purpose was to compare CLV vs standard of care (SOC) in dyspneic AHF.
Methods: This randomized open label 13 center trial enrolled ED AHF pts with pulmonary congestion, SBP ≥160 mm Hg, and ≥5 on a 10 cm visual analog dyspnea scale (VAS). After setting a 30 min target systolic BP (TBP) range, pts were randomized to CLV or SOC administered per approved labeling.
Results: Of 104 pts treated (safety pop), 54 (51.9%) were female and 83 (79.8%) African American; median (IQR) age, HR, SBP, BNP, initial VAS, and door-to-drug time were 57y (51, 70), 85.5 bpm (70, 96), 180 mmHg (170, 195), 630 pg/mL (353, 1260), 7cm (6, 8.4), and 148.5min (103.5, 219). Therapy was 51 CLV vs 53 SOC (30 nitroglycerin, 16 nicardipine, 4 ISDN and 1 each of hydralazine, nitroprusside, and diltiazem). In the first 30 min, 79.5% CLV and 53.7% SOC AHF pts reached TBP (p=0.011, a primary endpoint); 16 CLV and 1 SOC pt exceeded the median TBP lower limit (CLV 132.5, SOC 140.0 mmHg) by 8.0 and 13.0 mmHg, respectively. Overall, 68.2% CLV and 70.7% SOC (p = 0.579) had SBP values below TBP. No pt had a drug related Treatment-Emergent Adverse Event (TEAE) of symptomatic hypotension. At 45 minutes, VAS median (IQR) decreased more from baseline with CLV -3.6 (-5.2, -2.0), than SOC, -2.1 (-4.7, -1.2), p=0.012; an effect maintained to 3 hours. CLV pts needed fewer additional antihypertensives (19.9 vs 47.2%, p=0.004). CLV pts trended to fewer procedures (27.5 vs 34.0%, p=0.472), ICU admissions (22.9 vs 26.9%, p=0.644), and shorter hospital stays (median 4.0 vs 5.0 days, p=0.235). CLV and SOC had a similar incidence of drug related TEAEs (11.8% vs 13.2%, p=0.824). There were 5 deaths by 30 days (3 CLV, 2 SOC, p=0.615), none while on study drug.
Conclusions: CLV is more effective than SOC in rapidly controlling BP and improving dyspnea in AHF.
- © 2012 by American Heart Association, Inc.