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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 1

Study ID:

NCT02769611

Recruitment Status:

Withdrawn

Sponsor:

University of Tennessee

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

The Lindner Center for Research and Education at The Christ Hospital
Cincinnati Ohio, 45219, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Study ID:

NCT02769611

Recruitment Status:

Withdrawn

Sponsor:


University of Tennessee

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider