Heart Failure Clinical Trial
Ruboxistaurin in New York Heart Failure Classification III-IV Patients
Summary
This study evaluates the effect of ruboxistaurin for its safety, tolerability, and effectiveness in treating adult patients with heart failure. Patients will receive 1 dose of oral ruboxistaurin.
Full Description
Ruboxistaurin is a drug initially developed for treatment of diabetic peripheral retinopathy. The proposed indication for ruboxistaurin in this study is the treatment of adult patients with New York Heart Failure Association (NYHA) Class III-IV heart failure. Ruboxistaurin is a protein kinase c-alpha (PKC-alpha) inhibitor and thus will produce an inotropic effect in the heart which holds the potential to improve cardiac function.
Eligibility Criteria
Inclusion Criteria:
Male or female, 30-75 years of age, inclusive
NYHA Class III-IV heart failure (HF) confirmed left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) <40% as assessed by noninvasive imaging studies such as echocardiography or cardiac MRI within the last 6 months admitted with decompensated heart failure and almost ready for clinical discharge
Patient must have had adequate therapy for acute decompensated HF (heart failure) episode prior to enrollment
Exclusion Criteria:
Patients with acute coronary syndrome
Resynchronization therapy initiated less than 90 days prior to enrollment
(LVAD) left ventricular assist device or heart transplantation expected within the next 3 months
Patients on hemodialysis or end stage renal disease (ESRD)
Patients with serum albumin less than 3 g/dL or evidence of liver cirrhosis
Patients with uncontrolled arterial hypertension (systolic blood pressure > 180 or diastolic blood pressure >110)
Patients with severe valvular heart disease
Patients with acute myocarditis
Patients with serum creatinine >3.0 mg/dl or BUN >70 mg/dL
Patients with hemodynamic instability or significant active arrhythmias
Patients currently on intravenous inotropic therapy or those that have received inotropic therapy within the last 24 hours prior to study enrollment
Patients currently on CYP3A inhibitors, or patients that have taken CYP3A inhibitors within 3 months prior to enrollment
Patients with ongoing ischemia
Patients who have had a myocardial infarction within 30 days prior to study enrollment
Patients who are pregnant, nursing, or planning to become pregnant during the study period
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There is 1 Location for this study
Cincinnati Ohio, 45219, United States
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