The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC)

• Status: Terminated
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a proof of concept trial using ranolazine, a medication, in patients with known Coronary Artery Disease and reduced left ventricular function, EF < 40%. We propose that ranolazine therapy will result in demonstrative improvements in cardiac function that can be objectively assessed using the parameters measured with CPET. We propose that demonstrative improvement in CPET parameters on ranolazine will translate into improved patient outcomes for this patient population.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiovascular Institute of the South Clinical Research Corporation
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

Criteria

Inclusion Criteria:

• Patients > 18 years of age will be enrolled in the trial.

• Stable patients without hospitalizations, medication changes or cardiac intervention within one month of the study will be enrolled.

• Patients must be able to complete the CPET protocol and must have demonstrable ischemia on the initial CPET evaluation.

• Patients must have a documented ejection fraction < 40%

a. LV function can be assessed via: i. Echocardiogram ii. MUGA or Nuclear Perfusion Scan iii. Left ventriculogram

• Patients must be Ranexa naive and without contraindication for Ranexa therapy.

Exclusion Criteria:

• QTc>500 msec on resting EKG

• Hepatic Impairment (Child-Pugh class A, B or C)

• Have received prior treatment with ranolazine

• Treatment with QT prolonging drugs as class 1A (e.g., quinidine), class III (e.g., sotalol, dofetilide) anti-arrhythmics, amiodarone and anti-psychotics (e.g., thioridazine, ziprasidone)

• Treatment with potent or moderately potent CYP3A inhibitors including ketoconazole and other azole antifungals, diltiazem, verapamil, macrolide antibiotics, HIV protease inhibitors or consumption of grapefruit juice or grapefruit juice containing products

• Have participated in another trial of an investigational device or drug within 30 days of screening

• Have end stage renal disease requiring dialysis

• Have any chronic illness likely to effect compliance with the protocol

• Have second or third degree atrioventricular block in the absence of a functioning ventricular pacemaker

• Have uncontrolled clinically significant cardiac arrhythmias, or a history of ventricular fibrillation, torsade de pointes, or other life-threatening ventricular arrhythmias

• Uncontrolled HTN defined as BP > /= 160/100 mm Hg