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A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C — SEISMiC-C  

Cardiogenic Shock Clinical Trial

Official title:
A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C

Clinical Trial Summary

The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices. Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS. Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05975021
Study type Interventional
Source Windtree Therapeutics
Contact Phillip D Simmons, MS
Phone 215-488-9477
Email psimmons@windtreetx.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date December 1, 2023
Completion date July 1, 2024
View Details
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