Trial | NCT01979965  Report issue

Title

Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranolazine ...

  • Study Participants

    50
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.
Study Started
Nov 30
2013
Primary Completion
May 31
2014
Anticipated
Study Completion
Sep 30
2014
Anticipated
Last Update
Nov 08
2013
Estimate

Drug Ranolazine (Active drug)

Ranolazine therapy for three months

  • Other names: Ranexa

Drug Placebo

Placebo therapy for three months

Active drug Active Comparator

Ranolazine therapy for three months

Sugar Pill Placebo Comparator

sugar pill therapy for three months

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
No Results Posted