ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"

In order to be considered eligible subjects, the following entry criteria must be met: At least 18 years of age ischemic or nonischemic cardiomyopathy NYHA Class III or IV one hospitalization, or two outpatient visits, for the treatment of worsening heart failure within 12 months requiring the administration of I.V. heart failure therapy LVEDD >3.2 cm/m2 or >=6.0 cm LVEF of less than or equal to 30% concomitant treatment with optimal conventional heart failure therapy Exclusion Criteria Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study: Subjects on the following concomitant medications: Calcium antagonists other than amlodipine or felodipine Flecainide, encainide, propafenone, dofetilide or disopyramide Subjects receiving I.V. positive inotropic agents within seven days of the Screening Visit or Randomization Visit Subjects receiving a human B-type natriuretic peptide, including nesiritide, within seven days of the Screening Visit or Randomization Visit Subjects receiving oral or I.V. phosphodiesterase III inhibitors (PDEI III), including levosimendan and cilostazol, within seven days of the Screening Visit or Randomization Visit Subjects with active hepatic (screening serum total bilirubin >= 3.0 mg/dl (>=51.3 umol/l), renal (screening serum creatinine >= 2.0 mg/dl (=178.8 umol/l)), hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease Subjects with a serum potassium <4.0 mEq/L or >5.5 mEq/L (<4.0 mmol/l or >5.5 mmol/l) at Randomization Visit Subjects with a magnesium level of <1.0 mEq/L (<0.5 mmol/l) at Randomization Visit (Visit 0) Subjects with a serum digoxin of >1.2 ng/ml (>1.5 nmol/l) or a serum digitoxin of >20 ng/ml (>26.2 nmol/l) at the Randomization Visit are excluded. A target serum digoxin level of <=1.0 ng/ml (<=1.3 nmol/l) is recommended