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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. (NCT02769611)

The Christ Hospital
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.
  • Drug: Ruboxistaurin
    Dose escalation trial. 1st ten patients to receive 64 mg, next 10 patients to receive 128 mg, next 10 patients to receive 256 mg.
    • LY333531
Ages eligible for Study
30 Years to 75 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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
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.

1 locations

United States (1)
  • The Lindner Center for Research and Education at The Christ Hospital
    recruiting
    Cincinnati, Ohio, United States, 45219
Status:
recruiting
Type:
Interventional
Phase:
Ⅰ, Ⅱ
Start:
27 June, 2017
Updated:
11 February, 2018
Participants:
30
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