Trò choi tr?c tuy?n mi?n phí
Based on assessment of the data from the istaroxime phase 2 program in acute heart failure and the regulatory landscape, and after discussions with advisors, the Company has added an early cardiogenic shock study to the istaroxime development plan. Trò choi tr?c tuy?n mi?n phí Cardiogenic shock is a severe presentation of heart failure characterized by very low blood pressure and hypo-perfusion to critical organs. It is associated with high mortality and morbidity and is not well treated with current therapies. The Company believes istaroxime may fulfill an unmet need in cardiogenic shock based on the profile observed in prior phase 2 clinical studies in acute heart failure, which showed that istaroxime increased systolic blood pressure by 15 mmHg (1.5 ug/kg/min dose group), suggesting that istaroxime could potentially contribute to the clinical improvement of patients in cardiogenic shock due to heart failure. Because of the unmet need, there may be opportunities for an enhanced regulatory pathway and review. According to FDA published position and actions, approval in shock potentially could be based on blood pressure changes alone (assuming comparable mortality compared to control patients at 30 days). The Company plans to execute a small study of istaroxime in early cardiogenic shock patients to evaluate the potential to improve blood pressure and organ perfusion.

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