Ruboxistaurin in New York Heart Failure Classification III-IV Patients

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati; University of Tennessee
• Collaborator: The Christ Hospital
• Treatments: Ruboxistaurin

Criteria

Inclusion Criteria:

1. Male or female, 30-75 years of age, inclusive

2. 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

3. Patient must have had adequate therapy for acute decompensated HF (heart failure) episode prior to enrollment

Exclusion Criteria:

1. Patients with acute coronary syndrome

2. Resynchronization therapy initiated less than 90 days prior to enrollment

3. (LVAD) left ventricular assist device or heart transplantation expected within the next 3 months

4. Patients on hemodialysis or end stage renal disease (ESRD)

5. Patients with serum albumin less than 3 g/dL or evidence of liver cirrhosis

6. Patients with uncontrolled arterial hypertension (systolic blood pressure > 180 or diastolic blood pressure >110)

7. Patients with severe valvular heart disease

8. Patients with acute myocarditis

9. Patients with serum creatinine >3.0 mg/dl or BUN >70 mg/dL

10. Patients with hemodynamic instability or significant active arrhythmias

11. Patients currently on intravenous inotropic therapy or those that have received inotropic therapy within the last 24 hours prior to study enrollment

12. Patients currently on CYP3A inhibitors, or patients that have taken CYP3A inhibitors within 3 months prior to enrollment

13. Patients with ongoing ischemia

14. Patients who have had a myocardial infarction within 30 days prior to study enrollment

15. Patients who are pregnant, nursing, or planning to become pregnant during the study period