A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C (NCT05975021)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (33 items).
Location: Tufts Medical Center — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient is in SCAI B (BP increased above 90 mmHg despite no vasoactive or inotrope therapy) or SCAI D (continuously deteriorating BP and hypoperfusion despite vasoactive or inotrope therapy);
- Lactate \< 2 mmol/L (unless the patient meets the criteria in bullet 2 of Table 5-1) or lactate \> 5 mmol/L prior to randomization;
- Cardiogenic shock due to any other condition besides acute decompensation of chronic heart failure;
- Any of the following in the past 30 days: acute coronary syndrome, coronary revascularization, MI, CABG, or percutaneous coronary intervention;
- Current (within 6 hours of screening) or anticipated need for treatment with renal support including ultrafiltration, or mechanical circulatory, ventilatory or renal support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) such as persistent hypoperfusion and hypotension;
- History of heart transplant or UNOS priority 1a heart transplant listing
- Ongoing treatment with digoxin (if digoxin was stopped before signing the ICF and the digoxin plasma level is \< 0.5 ng/ml, the patient may be enrolled);
- Severe renal impairment (eGFR \< 30 ml/min, calculated by the MDRD formula);
- Hypersensitivity to the trial medication and its excipients (including known lactose hypersensitivity) or any related medication;
- Stroke or TIA within 3 months;
- Severe obstructive valvular lesions including severe aortic or mitral stenosis;
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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.