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NOT YET 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 mild to moderate cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. 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, having worsening heart failure, and/or increasing quality of life compared to a placebo? * Does istaroxime increase blood pressure compared to a placebo? Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure. Participants will: * Receive a 48-hour intravenous infusion of istaroxime or placebo * Complete questionnaires rating their breathing and describing their quality of life * Return for a visit 30 and 90 days after the initial drug infusion was started

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

2026-07

Completion Date

2028-12

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

istaroxime

intravenous istaroxime

DRUG

placebo

intravenous placebo