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

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ClinicalTrials.gov Identifier: NCT01979965
Recruitment Status : Unknown
Verified November 2013 by University Cardiology.
Recruitment status was:  Enrolling by invitation
First Posted : November 8, 2013
Last Update Posted : November 8, 2013
Sponsor:
Information provided by (Responsible Party):
University Cardiology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Mitral Regurgitation Drug: Ranolazine (Active drug) Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
Study Start Date : November 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active drug
Ranolazine therapy for three months
Drug: Ranolazine (Active drug)
Ranolazine therapy for three months
Other Name: Ranexa
Placebo Comparator: Sugar Pill
sugar pill therapy for three months
Drug: Placebo
Placebo therapy for three months



Primary Outcome Measures :
  1. effective regurgitant orifice by echocardiography [ Time Frame: Day T = 90 days ]
  2. proximal isovelocity surface area by echocardiography [ Time Frame: T = 90 days ]

Secondary Outcome Measures :
  1. Seattle Angina Questionnaire [ Time Frame: T = 0 days, and T = 90 days ]
  2. Rose Dyspnea Scale [ Time Frame: T = 0 days, and T= 90 days ]

Other Outcome Measures:
  1. Adverse Reactions [ Time Frame: T = 90 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979965


Locations
United States, Tennessee
University Cardiology
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
University Cardiology
Investigators
Principal Investigator: Raj Baljepally, MD University Cardiology

Additional Information:
Responsible Party: University Cardiology
ClinicalTrials.gov Identifier: NCT01979965     History of Changes
Other Study ID Numbers: IN-US-259-0173
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Keywords provided by University Cardiology:
Mitral Regurgitation
cardiac resynchronization therapy
ranolazine
maximal medical therapy
ischemic cardiomyopathy

Additional relevant MeSH terms:
Ischemia
Mitral Valve Insufficiency
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action