A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C (NCT05975021)
A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Tufts Medical Center — Boston, Massachusetts
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Tufts Medical Center — Boston, Massachusetts
- Oregon Health and Sciences University — Portland, Oregon
- Sanatorio Güemes — Capital Federal, Buenos Aires
- Sanatorio De la Trinidad Palermo — Capital Federal, Buenos Aires
- Instituto Cardiovascular de Rosario — Rosario, Sante Fe
- Hospital Privado de Rosario — Rosario, Sante Fe
- 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,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cardiogenic Shock
- Augmented Pacing for Shock in the Cardiac Intensive Care Unit — Nashville, Tennessee
- Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock — Loma Linda, California
- CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock — Boston, Massachusetts
- Intra-aortic Balloon Counterpulsation (IABC) Compliance — Philadelphia, Pennsylvania
- Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial — Falls Church, Virginia
Explore by condition: All Cardiogenic Shock clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.