NCT05975021

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DRUG	Istaroxime	IV infusion via a syringe pump. Dosage of 1.0 µg/kg/min for 6 hours; 0.5 µg/kg/min for 42 hours. Total duration 48 hours.
DRUG	Placebo	IV infusion via a syringe pump. Total duration 48 hours.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-07-28
• Completion: 2026-08-31
• First posted: 2023-08-03
• Last updated: 2025-08-20

Locations

15 sites across 5 countries: United States, Argentina, Israel, Italy, Poland

Regulatory

• FDA-regulated drug study