The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock

Summary

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

Timeline

Start

2020-09-28

Primary completion

2024-09-26

Completion

2024-10-30

Outcome

Met primary endpoint

paper 53.1 (standard error [SE] 6.88) mmHg × hour versus 30.9 (SE 6.76) mmHg × hour with istaroxime versus placebo (p = 0.017). PMID 35867804 ↗

Publications

• Results Metra M, Chioncel O, Cotter G, Davison B, Filippatos G, Mebazaa A, Novosadova M, Ponikowski P, Simmons P, Soffer J, Simonson S. Safety and efficacy of istaroxime in patients with acute heart failure-related pre-cardiogenic shock - a multicentre, randomized, double-blind, placebo-controlled, parallel group study (SEISMiC). Eur J Heart Fail. 2022 Oct;24(10):1967-1977. doi: 10.1002/ejhf.2629. Epub 2022 Aug 22.
• Results Metra M, Chioncel O, Davison B, Filippatos G, Mebazaa A, Pagnesi M, Adamo M, Novosadova M, Ponikowski P, Simmons P, Soffer J, Simonson S, Cotter G. Safety and Efficacy of Istaroxime 1.0 and 1.5 microg/kg/min for Patients With Pre-Cardiogenic Shock. J Card Fail. 2023 Jul;29(7):1097-1103. doi: 10.1016/j.cardfail.2023.03.020. Epub 2023 Apr 17.

Drugs

Indications