Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy

The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.

Inclusion Criteria:

• Ischemic cardiomyopathy AND
• Moderate or severe mitral regurgitation AND
• Cardiac resynchronization therapy (CRT) ≥ 3 months prior to enrollment AND
• Maximal Medical Therapy (ACE-Inhibitor, beta blocker, aldosterone antagonist, diuretic, aspirin, statin)

Exclusion Criteria:

• nonischemic cardiomyopathy
• active heart failure
• current ranolazine therapy
• congenital heart disease
• mechanical valve prostheses
• vegetation/endocarditis
• significant pulmonary disease
• peripheral vascular disease
• trivial or mild mitral regurgitation
• creatinine clearance < 30 mL/min
• liver cirrhosis
• strong inhibitors of CYP3A (including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
• strong inducers of CYP3A (including rifampin, rifapentine, phenobarbital, phenytoin, carbamazepine and St.John's wort)
• Strong P-glycoprotein inhibitors (including cyclosporine, verapamil, and quinidine)
• Initial QTc interval ≥ 440msec