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
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Locations near you
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Full eligibility criteria for NCT02769611
Ages eligible for Study
30 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02769611
United States (1)
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
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View full eligibility
Tris trial is registered with FDA with number: NCT02769611. The sponsor of the trial is Children's Hospital Medical Center, Cincinnati and it is looking for 30 volunteers for the current phase.
Official trial title: A Prospective Phase I/II Dose Escalation Pilot Analysis of Ruboxistaurin (LY333531) for Safety in New York Heart Failure Classification III-IV Patients, As Well As For Efficacy in Acutely Augmenting Cardiac Function.
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