Ruboxistaurin in New York Heart Failure Classification III-IV Patients

University of Tennessee

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Heart Failure

Treatments: Drug: Ruboxistaurin

Study type: Interventional

Funder types: Other

Identifiers

NCT02769611

2013-7007

Details and patient eligibility

About

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.

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Ruboxistaurin 64 mg

Experimental group

Description:

ruboxistaurin, 64 mg as 1 capsule by mouth with water, 1 time administration

Treatment:

Drug: Ruboxistaurin

Ruboxistaurin 128 mg

Experimental group

Description:

ruboxistaurin, 128 mg as 2 capsules by mouth with water, 1 time administration

Treatment:

Drug: Ruboxistaurin

Ruboxistaurin 256 mg

Experimental group

Description:

ruboxistaurin, 256 mg as 4 capsules by mouth with water, 1 time administration

Treatment:

Drug: Ruboxistaurin