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A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C
Sponsor: Windtree Therapeutics
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.
Official title: A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-06-01
Completion Date
2026-08-31
Last Updated
2025-08-20
Healthy Volunteers
No
Conditions
Interventions
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.
Placebo
IV infusion via a syringe pump. Total duration 48 hours.
Locations (15)
Tufts Medical Center
Boston, Massachusetts, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Sanatorio Güemes
Capital Federal, Buenos Aires, Argentina
Sanatorio De la Trinidad Palermo
Capital Federal, Buenos Aires, Argentina
Instituto Cardiovascular de Rosario
Rosario, Sante Fe, Argentina
Hospital Privado de Rosario
Rosario, Sante Fe, Argentina
Kaplan Medical Center
Rehovot, Israel
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
IRCCS San Raffaele Scientific Institute
Milan, Italy
University of Turin, Città della Salute e della Scienza
Turin, Italy
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Uniwersytecki Szpital Kliniczny, Instytut Chorob Serca
Wroclaw, Poland
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Poland