The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure

Summary

To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure.

Timeline

Start

2015-12

Primary completion

2018-08-14

Completion

2019-02-06

Outcome

Met primary endpoint

registry analysis (superiority test); Istaroxime 0.5 µg/kg/Min vs Placebo Cohort I; p = 0.029; Mean Difference (Final Values) -3.00 (95% CI -5.68 to -0.32); ANOVA; note: Alpha set at 0.05. NCT02617446 ↗

registry analysis (superiority test); Istaroxime 1.0 µg/kg/Min vs Placebo Cohort II; p = 0.009; Mean Difference (Final Values) -2.08 (95% CI -3.61 to -0.55); ANOVA; note: Alpha set at 0.05. NCT02617446 ↗

paper The primary endpoint of change in E/e' ratio from baseline to 24 h decreased with istaroxime vs. placebo PMID 31975496 ↗

Publications

• Results Carubelli V, Zhang Y, Metra M, Lombardi C, Felker GM, Filippatos G, O'Connor CM, Teerlink JR, Simmons P, Segal R, Malfatto G, La Rovere MT, Li D, Han X, Yuan Z, Yao Y, Li B, Lau LF, Bianchi G, Zhang J; Istaroxime ADHF Trial Group. Treatment with 24 hour istaroxime infusion in patients hospitalised for acute heart failure: a randomised, placebo-controlled trial. Eur J Heart Fail. 2020 Sep;22(9):1684-1693. doi: 10.1002/ejhf.1743. Epub 2020 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Istaroxime	Small molecule	0.5 ug/kg	Intravenous
Subject	Istaroxime	Small molecule	1 ug/kg	Intravenous

Indications