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The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock

NCT04325035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-04

No results posted yet for this study

Summary

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

Conditions

  • Cardiogenic Shock

Interventions

DRUG

Istaroxime

Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion

DRUG

Placebo

Reconstituted placebo (lactose lyophilized powder) delivered via IV infusion

Sponsors & Collaborators

  • Momentum Research, Inc.

    collaborator INDUSTRY

  • Windtree Therapeutics

    lead INDUSTRY

Principal Investigators

  • Marco Metra, MD · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2024-09-26
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Italy
  • Poland

Study Locations

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Entities

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 NCT04325035 on ClinicalTrials.gov