Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
NCT ID: NCT01979965
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2013-11-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Active drug
Ranolazine therapy for three months
Ranolazine (Active drug)
Ranolazine therapy for three months
Sugar Pill
sugar pill therapy for three months
Placebo
Placebo therapy for three months
Interventions
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Ranolazine (Active drug)
Ranolazine therapy for three months
Placebo
Placebo therapy for three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Cardiology
OTHER
Responsible Party
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Principal Investigators
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Raj Baljepally, MD
Role: PRINCIPAL_INVESTIGATOR
University Cardiology
Locations
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University Cardiology
Knoxville, Tennessee, United States
Countries
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Related Links
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University Cardiology
Other Identifiers
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IN-US-259-0173
Identifier Type: -
Identifier Source: org_study_id
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