A randomized, double-blind, Multicenter, parallel, placebo-controlled study
The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous
infusion of Levosimendan for 24hrs in patients with ADHF who will be hospitalized with ADHF
and continue to have symptom of dyspnea at rest(NYHA Class III or IV) despite with treatment
of SOCs(include intravenous diuretics, vasodilators and/or positive inotropic drugs but
except amrinone and milrinone) within 48hrs
Efficacy is measured by Clinical composite classification(Improved, No change, Worse),
bio-marker(change of BNP and ST-2), Patient's Global Assessment, NYHA functional
Classification, hospitalization period and renal function tests(change of creatinine, BUN and
NGAL) Safety is measured by recording the incidence of adverse events(AEs), vital signs,
clinical blood safety tests(biochemistry, hematology) and concomitant medications
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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