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NCT05975021 · ClinicalTrials.gov registry record · Phase 1

A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C

A Phase 1 study of Cardiogenic Shock, sponsored by Windtree Therapeutics.

Active
Registry status
Phase 1
Development phase
20
Enrollment target
15
Study locations

NCT05975021 is a Phase 1 study of Cardiogenic Shock that is active but no longer recruiting, run by Windtree Therapeutics. The registered enrollment target is 20 participants, below the 633-participant average among 16 other Cardiogenic Shock trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 5 states.

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The verdict

NCT05975021, a Phase 1 study of Cardiogenic Shock, is active but no longer recruiting, sponsored by Windtree Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
20 participants
Enrollment target
15
Study locations

Study Summary

The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices. Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS. Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.

Conditions Studied

Cardiogenic Shock

Interventions

  • DRUG Placebo
  • DRUG Istaroxime

Study Locations (15)

Other

  • Kaplan Medical Center - Rehovot
  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo - Alessandria
  • ASST degli Spedali Civili di Brescia - Brescia
  • IRCCS San Raffaele Scientific Institute - Milan
  • University of Turin, Città della Salute e della Scienza - Turin
  • Uniwersytecki Szpital Kliniczny w Białymstoku - Bialystok
  • Uniwersytecki Szpital Kliniczny w Opolu - Opole
  • Uniwersytecki Szpital Kliniczny, Instytut Chorob Serca - Wroclaw
  • 4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ - Wroclaw

Buenos Aires

  • Sanatorio Güemes - Capital Federal
  • Sanatorio De la Trinidad Palermo - Capital Federal

Sante Fe

  • Instituto Cardiovascular de Rosario - Rosario
  • Hospital Privado de Rosario - Rosario

Massachusetts

  • Tufts Medical Center - Boston

Oregon

  • Oregon Health and Sciences University - Portland

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-06-01
Est. Completion 2026-08-31
Phase Phase 1

Sponsor

Windtree Therapeutics

11 total trials

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What the Registry Record Tells You About NCT05975021

The ClinicalTrials.gov registry entry for NCT05975021 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 633-participant average among 16 other Cardiogenic Shock trials with a reported enrollment target (97% lower). The listed sponsor is Windtree Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiogenic Shock appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05975021 reports 15 study locations spanning 5 distinct geographic areas - top geographies include Other, Buenos Aires, Sante Fe.

Frequently Asked Questions

What is clinical trial NCT05975021 about?

NCT05975021 is a clinical study titled "A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C". The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low bl...

What is the current status of trial NCT05975021?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-06-01. Estimated completion is 2026-08-31.

What conditions does trial NCT05975021 study?

This clinical trial studies the following conditions: Cardiogenic Shock.

What interventions are being tested in trial NCT05975021?

The interventions under investigation include: Placebo (DRUG), Istaroxime (DRUG).

Who is sponsoring clinical trial NCT05975021?

This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05975021 being conducted?

This trial has 15 study locations across Massachusetts, Oregon, Buenos Aires, Sante Fe. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.