Ruboxistaurin in New York Heart Failure Classification III-IV Patients

NCT ID: NCT02769611

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2022-01-01

Brief 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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruboxistaurin 64 mg

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

Group Type: EXPERIMENTAL

Ruboxistaurin

Intervention Type: DRUG

Dose escalation trial. 1st ten patients to receive 64 mg, next 10 patients to receive 128 mg, next 10 patients to receive 256 mg.

Ruboxistaurin 128 mg

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

Group Type: EXPERIMENTAL

Ruboxistaurin

Intervention Type: DRUG

Dose escalation trial. 1st ten patients to receive 64 mg, next 10 patients to receive 128 mg, next 10 patients to receive 256 mg.

Ruboxistaurin 256 mg

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

Group Type: EXPERIMENTAL

Ruboxistaurin

Intervention Type: DRUG

Dose escalation trial. 1st ten patients to receive 64 mg, next 10 patients to receive 128 mg, next 10 patients to receive 256 mg.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

LY333531

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christ Hospital

OTHER

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John L Jefferies, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2013-7007

Identifier Type: -

Identifier Source: org_study_id