Study-Specific Design Considerations Sample Clauses

Study-Specific Design Considerations. The current study is a randomized, double-blind study of levosimendan in addition to standard of care compared with standard of care. The study population is well defined (documented LVEF £ 30% with or without congestive heart failure [NYHA Class I to IV] who are undergoing 1) CABG with or without mitral valve repair or replacement or 2) isolated mitral valve repair/replacement, and who will be placed on CPB during surgery and 18 years or older). Both treatment groups will receive the standard of care therapy in addition to study drug (levosimendan or placebo). The study is blinded to reduce treatment and assessment bias during the study. Levosimendan is approved for the treatment of acute decompensated heart failure and has been shown to decrease morbidity and mortality in small studies that included similar subject population to the target population in this study. Therefore, it is reasonable to study whether or not the addition of levosimendan to standard of care therapy can provide additional and meaningful clinical benefit to patients with left ventricular systolic dysfunction undergoing cardiac surgery. The assessment of the safety of levosimendan in the literature is consistent in that no clinical studies evaluating patients with either heart failure or patients undergoing cardiac surgery have reported increased all-cause mortality. The target population in this study is quite distinct from those previously studied in large randomized clinical trial (e.g., acute decompensated heart failure, chronic heart failure) in that subjects in this study not only have left ventricular systolic dysfunction with or without a history of congestive heart failure, but are also undergoing cardiac surgery on CPB. The pathophysiology of their condition, the effect of surgery and CPB, as well as the type and proportion of standard of care therapies are therefore quite unique in this study. Further, a meta-analysis performed by DCRI of all available studies evaluating levosimendan in patients undergoing cardiac surgery showed encouraging results from morbidity and mortality standpoint. All participating subjects will receive standard of care treatment and will be followed closely for safety and efficacy. This study is therefore undertaken to further clarify the benefit-risk profile associated with levosimendan in subjects with pre-existing left ventricular systolic dysfunction undergoing cardiac surgery on CPB. Efficacy assessments will occur according to generally acce...
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Related to Study-Specific Design Considerations

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