NCT04325035

The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a pilot, multinational, multicenter, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of males or females 18 to 85 years of age, hospitalized for acute decompensated heart failure (ADHF) with persistent hypotension (systolic blood pressure \[SBP\] 70-100 mmHg for two hours). Part A will dose all subjects for 24 hours with either 1.0 µg/kg/min or placebo; Part B will dose all subjects for 60 hours with two different regimens of istaroxime or placebo. Enrollment of Part A and Part B will be sequential. Up to 30 sites in Part A; up to 15 sites in Part B. Sites may be located in Europe, Asia, South America, and North America.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DRUG	Istaroxime	Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion
DRUG	Placebo	Reconstituted placebo (lactose lyophilized powder) delivered via IV infusion

Timeline

• Start date: 2020-09-28
• Primary completion: 2024-09-26
• Completion: 2024-10-30
• First posted: 2020-03-27
• Last updated: 2025-02-04

Locations

13 sites across 4 countries: United States, Argentina, Italy, Poland

Regulatory

• FDA-regulated drug study