The goal of this clinical trial is to learn if the drug istaroxime works to treat cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat cardiogenic shock due to acute heart failure.
The main questions it aims to answer are:
* Does istaroxime relieve participants' shortness of breath compared to a placebo? * Does istaroxime provide clinical benefit in terms of lowering the risk of dying, having invasive procedures, being rehospitalized or having worsening heart failure, and/or increasing quality of life compared to a placebo? * Does istaroxime reduce the duration of the initial hospital stay compared with placebo?
Participants will:
* Receive a 48-hour intravenous infusion of istaroxime or placebo with possible additional retreatment depending on their clinical condition * Complete questionnaires rating their breathing and describing their quality of life * Return for visits 30 and 90 days after the start of Cycle 1 infusion. The trial will end when the last participant completes Day 30 and all participants have been followed for at least 30 days after their last IMP exposure. At trial termination, participants who have not been followed to Day 90 will have an end-of-study (EOS) visit.
Aged between 18 and 80 years old (inclusive) at the time of informed consent, regardless of gender.
Dyspnea at rest or with minimal activity before screening and randomization.
Pulmonary rales, or lower limb edema by physical examination.
Evidence of pulmonary congestion by chest X-ray, CT scan or lung ultrasound
Body weight < 40 kg or ≥ 150 kg at Screening.
Rapidly deteriorating cardiogenic shock requiring escalating support
Patients with any systolic blood pressure measurement >130 mmHg within 2 hours prior to randomization.
Administration during the 6 hours prior to screening of vasodilators such as nitroglycerin, nitrates, recombinant human brain natriuretic peptide.
Parallel
istaroxime
Drugintravenous istaroxime
placebo
Drugintravenous placebo
Change in participant-reported dyspnea
Area under the curve (AUC) of change from baseline in dyspnea visual analog scale (VAS) score (0-100; higher scores indicate better breathing).
Hierarchical composite endpoint
Hierarchical composite of (1) time to all-cause death; (2) time to first initiation of new mechanical circulatory support, urgent durable LVAD implantation or heart transplantation, or invasive mechanical respiratory support; (3) time to first heart failure rehospitalization or worsening heart failure; and (4) change from baseline in EQ-VAS score (0-100; higher scores indicate better health).
Length of hospital stay
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