SEISMiC topline results: Istaroxime improves systolic BP profile in cardiogenic shock
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In the phase 2 SEISMiC trial, istaroxime met its primary endpoint of improving systolic BP profile at 6 hours in patients with cardiogenic shock, according to the topline results announced by Windtree Therapeutics.
SEISMiC is an international, randomized, double-blind, placebo-controlled phase 2 study in which researchers enrolled 60 patients with Society for Cardiovascular Angiography and Interventions stage B early cardiogenic shock due to severe HF with systolic BP of 75 mm Hg to 90 mm Hg.
Istaroxime is a first-in-class positive inotropic agent designed to improve systolic and diastolic cardiac function by increasing myocardial contractility and myocardial relaxation, according to the release.
Participants were randomly assigned to istaroxime (1 g/kg/min or 1.5 g/kg/min doses) or placebo infusion for 24 hours. The primary endpoint was the difference in systolic BP over 6 hours after infusion initiation. Secondary endpoints included BP changes over 24 hours, systolic and diastolic cardiac function, renal function and safety and tolerability.
The study met its primary endpoint in systolic BP profile over 6 hours, and the istaroxime-treated group performed significantly better compared with the control group, according to the release.
The full results of the SEISMiC phase 2 trial are planned to be presented at the European Society of Cardiology Heart Failure meeting in Madrid from May 21 to 24.
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