Effect of Ranolazine on Valvular Disease in Patients With Pacemakers (REIN-MR)

University Cardiology

Status and phase

Unknown

Phase 4

Conditions

Ischemic Mitral Regurgitation

Treatments

Drug: Ranolazine (Active drug)

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01979965

IN-US-259-0173

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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