Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Mitral Regurgitation

Intervention / Treatment
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* Drug: Ranolazine (Active drug)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active drug<br>Ranolazine therapy for three months | Drug: Ranolazine (Active drug)<br>* Ranolazine therapy for three months<br>* Other names: Ranexa;|
| Placebo Comparator: Sugar Pill<br>sugar pill therapy for three months | Drug: Placebo<br>* Placebo therapy for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective regurgitant orifice by echocardiography |  | Day T = 90 days | 
| proximal isovelocity surface area by echocardiography |  | T = 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seattle Angina Questionnaire |  | T = 0 days, and T = 90 days | 
| Rose Dyspnea Scale |  | T = 0 days, and T= 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Regurgitation, cardiac resynchronization therapy, ranolazine, maximal medical therapy, ischemic cardiomyopathy