A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the minimum effective dose of Istaroxime, in
patients requiring hospitalization for deterioration of chronic heart failure and left
ventricular systolic dysfunction. This goal will be reached by comparing the hemodynamic
effect of three different doses of the drug versus placebo. Efficacy will be measured as a
change in Pulmonary Capillary Wedge Pressure from pre-infusion to the last assessment at six
hours intravenous infusion.Secondary objectives will be to evaluate safety, tolerability and
efficacy on other main hemodynamic parameters, echocardiographic and echo-doppler
measurements, plus preliminary pharmacokinetics of the drug.