Safety and Efficacy Study of Istaroxime in Acute Decompensated Heart Failure Patients
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety and efficacy of istaroxime in patients
hospitalized for Acute Decompensated Heart Failure (ADHF) not requiring inotropic
therapy.This will be done by comparing the hemodynamic effect of a 24-hour infusion 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 6 hours after infusion start.
Secondary objectives will include the evaluation of clinical efficacy and safety through
assessment of cardiovascular and renal tolerability as well as changes in biological markers
such as brain natriuretic peptide (BNP) and troponin I (TNI), and the neurohormones renin and
aldosterone and also to assess the pharmacokinetics of istaroxime and its metabolites.