Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Ischemic Mitral Regurgitation
In brief
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.
Key facts
- Study ID
- NCT01979965
- Run by
- University Cardiology
- People needed
- 50
- Starts
- 2013-11-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2013-11-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University Cardiology — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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