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A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C
NCT05975021 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05975021
The ClinicalTrials.gov registry entry for NCT05975021 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Windtree Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05975021 reports 15 study locations spanning 5 distinct geographic areas — top geographies include Other, Buenos Aires, Sante Fe. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05975021?
The interventions under investigation include: Placebo (DRUG), Istaroxime (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05975021?
This trial is sponsored by Windtree Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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