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ACTIVE NOT RECRUITING
NCT05975021
PHASE1/PHASE2

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

Sponsor: Windtree Therapeutics

View on ClinicalTrials.gov

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

Interventions

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.

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