Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Cardiology
• Treatments: Ranolazine

Criteria

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