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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by University Cardiology.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979965
First Posted: November 8, 2013
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Cardiology
October 23, 2013
November 8, 2013
November 8, 2013
November 2013
May 2014   (Final data collection date for primary outcome measure)
  • effective regurgitant orifice by echocardiography [ Time Frame: Day T = 90 days ]
  • proximal isovelocity surface area by echocardiography [ Time Frame: T = 90 days ]
Same as current
No Changes Posted
  • Seattle Angina Questionnaire [ Time Frame: T = 0 days, and T = 90 days ]
  • Rose Dyspnea Scale [ Time Frame: T = 0 days, and T= 90 days ]
Same as current
Adverse Reactions [ Time Frame: T = 90 day ]
Same as current
 
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Ischemic Mitral Regurgitation
  • Drug: Ranolazine (Active drug)
    Ranolazine therapy for three months
    Other Name: Ranexa
  • Drug: Placebo
    Placebo therapy for three months
  • Active Comparator: Active drug
    Ranolazine therapy for three months
    Intervention: Drug: Ranolazine (Active drug)
  • Placebo Comparator: Sugar Pill
    sugar pill therapy for three months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
September 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01979965
IN-US-259-0173
Yes
Not Provided
Not Provided
University Cardiology
University Cardiology
Not Provided
Principal Investigator: Raj Baljepally, MD University Cardiology
University Cardiology
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP