Efficacy and safety of a calcium sensitizer, levosimendan, in patients with right heart failure due to pulmonary hypertension.
Efficacy and safety of a calcium sensitizer, levosimendan, in patients with right heart failure due to pulmonary hypertension
Background: Despite using vasoactive and PH specific therapies, the in-hospital mortality of severe pulmonary hypertension (PH) with right heart failure (RHF) is high. We conducted a prospective analysis evaluating the efficacy and safety of levosimendan in PH patients with severe acute RHF.
Methods: Forty-five PH patients hospitalized between Jan 2016 to Nov 2016 were recruited into a single arm, prospective, open-label study. Levosimendan was administered at the rate of 0.05-0.1 μg/kg/min, up to a total dose of 12.5 mg. The primary endpoints were changes of World Health Organization Function Class (WHO-FC) and Borg dyspnoea scores. Secondary endpoints included changes in 6-min walk distance (6-MWD), biochemical markers and right heart structure and function together with adverse events on day 7, and incidence of major cardiovascular events (death or re-admission due to RHF) on day 30.
Results: Forty-five PH patients were enrolled. On the 7th day after levosimendan infusion, seven out of 13 PH patients with WHO-FC IV improved by one class (P = 0.008). Borg dyspnoea scores, 6-MWD and NT-proBNP improved significantly (P < 0.001). Compared with baseline, the right atrial transverse dimension, end-systolic eccentricity index and tricuspid annular plane systolic excursion improved significantly (58.8 ± 13.1 mm vs. 53.7 ± 12.4 mm; 1.50 ± 0.27 vs. 1.38 ± 0.23; 15.0 (13.0, 16.0) mm vs. 15.8 (14.0, 17.4) mm, P < 0.005, respectively). One patient occurred sudden death after discharge during follow-up.
Conclusions: Intravenous levosimendan can effectively improve severe RHF of PH patients in hospital and well tolerated.