Acute cardiac care & resuscitation

Safety and Efficacy of up to 60 h of iv Istaroxime in Pre-Cardiogenic Shock Patients: Design of the SEISMiC Trial

ESC Heart FailPublished Randomised controlled trial

Study context

Population
Patients hospitalised for decompensated HF (pre-CS, not related to myocardial ischaemia) with persistent hypotension (systolic blood pressure (SBP) 70–100 mmHg for ≥2 h), clinically confirmed congestion, NT-proBNP ≥1400 pg/mL and LVEF≤40%; no IV vasopressors, inotropes or digoxin in past 6 h
Planned comparison
IV istaroxime vs placebo for up to 60 h
Primary endpoint
SBP area under the curve from baseline, in combined Parts A and B population
Follow-up
6 and 24 h
Methodological detailsdesign paper, multinational, multicentre, double-blind, placebo-controlled, two parts (A and B)
  • Design paper
  • Multinational
  • Multicentre
  • Double-blind
  • Placebo-controlled
  • Two parts (A and B)

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Safety and Efficacy of up to 60 h of iv Istaroxime in Pre-Cardiogenic Shock Patients: Design of the SEISMiC Trial. ESC Heart Fail. Published 7 October 2024. doi:10.1002/ehf2.15102

Summarised from the published abstract; every number is checked against it

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