Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04325035 | The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock | PHASE2 | COMPLETED | 90 | — | — | Sep 28, 2020 | Oct 30, 2024 | Feb 4, 2025 | 13 | United States, Argentina +2 |
| NCT05975021 | A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C | PHASE1 | ACTIVE NOT_RECRUITING | 20 | — | — | Jun 1, 2024 | Aug 31, 2026 | Aug 20, 2025 | 15 | United States, Argentina +3 |
Change from baseline AUC for systolic blood pressure
Systolic blood pressure (SBP) area under the curve (AUC) from start of infusion to 6 hours
| Arm | Type | Description |
|---|---|---|
| Istaroxime - Part A | EXPERIMENTAL | Istaroxime IV infusion for 24 hours. Istaroxime administration can begin at 1.0 or 1.5 µg/kg/min; the target infusion rate is 1.5 µg/kg/min |
| Placebo - Part A | PLACEBO_COMPARATOR | Placebo (lactose lyophilized powder) IV infusion for 24 hours |
| Istaroxime - Part B | EXPERIMENTAL | Istaroxime IV infusion at 1.0 µg/kg/min for 6 hours, 0.5 µg/kg/min for 42 hours, 0.25 µg/kg/min for 12 hours. |
| Istaroxime and Placebo - Part B | EXPERIMENTAL | Istaroxime IV infusion at 0.5 µg/kg/min for 48 hours, followed by placebo IV infusion for 12 hours. |
| Placebo - Part B | PLACEBO_COMPARATOR | Placebo (lactose lyophilized powder) IV infusion for 60 hours. |
| Istaroxime | EXPERIMENTAL | Istaroxime delivered as an IV infusion via a syringe pump. Dosage regime is 1.0 µg/kg/min for 6 hours, 0.5 µg/kg/min for 42 hours. Total duration 48 hours. |
| Placebo | PLACEBO_COMPARATOR | Placebo (lactose) delivered as an IV infusion via a syringe pump. Total duration 48 hours. |
| Name | Type | Description |
|---|---|---|
| Istaroxime | DRUG | Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion |
| Placebo | DRUG | Reconstituted placebo (lactose lyophilized powder) delivered via IV infusion |
Inclusion Criteria: 1. Clinical presentation consistent with SCAI Stage B pre-cardiogenic shock caused by acute decompensation of chronic systolic heart failure (due to arterial hypertension, ischemic heart disease or dilated cardiomyopathy), without evidence for an acute coronary syndrome. 2. Sign...