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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: Active Phase 1 study of Cardiogenic Shock, sponsored by Windtree Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Systolic blood pressure (SBP) area under the curve (AUC) from start of infusion to 6 hours
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 |
What the registry record for NCT05975021 still lists
NCT05975021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 633-participant average among 16 other Cardiogenic Shock trials with a reported enrollment target (97% lower).
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 lists 15 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Cardiogenic Shock
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05975021's enrollment target sits among peer trials
20 15th of 16 higher than 1 of 16 other Cardiogenic Shock trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiogenic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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