The goal of this clinical trial is to learn if the drug istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. 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, having worsening heart failure, and/or increasing quality of life compared to a placebo? * Does istaroxime increase blood pressure compared to a placebo? Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure.
Participants will:
* Receive a 48-hour intravenous infusion of istaroxime or placebo * Complete questionnaires rating their breathing and describing their quality of life * Return for a visit 30 and 90 days after the initial drug infusion was started
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.
Society for Cardiovascular Angiography and Interventions (SCAI) level D or more severe cardiogenic shock during screening, prior to randomization.
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 systolic BP
composite outcome
Hierarchical composite of death, mechanical circulatory support, worsening heart failure, quality of life assessed using the 'win ratio' method. Quality of life measured on a scale from 0=worst to 100=best. Measured using the percentage of wins among all possible comparisons between patients.
shortnes of breath
Measured on a scale from 0=worst to 100=best breathing
lenght of hospital stay
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This trial is not recruiting at the moment. You can still explore other options:
