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The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure

NCT02617446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-24

Study results available
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Summary

To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure.

Conditions

  • Acute Decompensated Heart Failure

Interventions

DRUG

Placebo

IV of matching saline solution

DRUG

Istaroxime

IV infusion of 0.5 µg/kg/min or 1.0 µg/kg/min istaroxime

Sponsors & Collaborators

  • Windtree Therapeutics

    lead INDUSTRY

Principal Investigators

  • Giuseppe Bianchi, MD · Windtree Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-08-14
Completion
2019-02-06
FDA Drug
Yes

Countries

  • China
  • Italy

Study Locations

More Related Trials

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 NCT02617446 on ClinicalTrials.gov