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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Cardiology
ClinicalTrials.gov Identifier:
NCT01979965
First received: October 23, 2013
Last updated: November 7, 2013
Last verified: November 2013

October 23, 2013
November 7, 2013
November 2013
May 2014   (final data collection date for primary outcome measure)
  • effective regurgitant orifice by echocardiography [ Time Frame: Day T = 90 days ] [ Designated as safety issue: No ]
  • proximal isovelocity surface area by echocardiography [ Time Frame: T = 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01979965 on ClinicalTrials.gov Archive Site
  • Seattle Angina Questionnaire [ Time Frame: T = 0 days, and T = 90 days ] [ Designated as safety issue: No ]
  • Rose Dyspnea Scale [ Time Frame: T = 0 days, and T= 90 days ] [ Designated as safety issue: No ]
Same as current
Adverse Reactions [ Time Frame: T = 90 day ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Enrolling by invitation
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01979965
IN-US-259-0173
Yes
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