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RECRUITING
NCT07583446
PHASE2/PHASE3

Randomized Evaluation of Istaroxime for Stabilization in Acute Heart Failure-Cardiogenic Shock

Sponsor: Seismic Pharmaceuticals Operations LLC

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the drug istaroxime works to treat cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat cardiogenic shock due to acute heart failure. The main questions it aims to answer are: * Does istaroxime relieve participants' shortness of breath compared to a placebo? * Does istaroxime provide clinical benefit in terms of lowering the risk of dying, having invasive procedures, being rehospitalized or having worsening heart failure, and/or increasing quality of life compared to a placebo? * Does istaroxime reduce the duration of the initial hospital stay compared with placebo? Participants will: * Receive a 48-hour intravenous infusion of istaroxime or placebo with possible additional retreatment depending on their clinical condition * Complete questionnaires rating their breathing and describing their quality of life * Return for visits 30 and 90 days after the start of Cycle 1 infusion. The trial will end when the last participant completes Day 30 and all participants have been followed for at least 30 days after their last IMP exposure. At trial termination, participants who have not been followed to Day 90 will have an end-of-study (EOS) visit.

Official title: A Randomized, Double-blind, Phase 2b/3 Clinical Study of Istaroxime Combined With Standard Care Versus Placebo and Standard of Care for the Treatment of Cardiogenic Shock (CS) Society for Cardiovascular Angiography and Interventions (SCAI) Stage B or C Due to Acute Heart Failure (AHF)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-09-09

Completion Date

2028-12

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DRUG

istaroxime

intravenous istaroxime

DRUG

placebo

intravenous placebo

Locations (1)

Institute of Surgery Mikayelyan CJSC

Yerevan, Armenia