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

NCT07583446 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-13

No results posted yet for this study

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

Conditions

  • Cardiogenic Shock

Interventions

DRUG

istaroxime

intravenous istaroxime

DRUG

placebo

intravenous placebo

Sponsors & Collaborators

  • Seismic Pharmaceuticals Operations LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2028-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583446 on ClinicalTrials.gov