Back to resultsEffect of Ranolazine on Valvular Disease in Patients With Pacemakers (REIN-MR)
Primary Purpose
Ischemic Mitral Regurgitation
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranolazine (Active drug)
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Ischemic Mitral Regurgitation focused on measuring Mitral Regurgitation, cardiac resynchronization therapy, ranolazine, maximal medical therapy, ischemic cardiomyopathy
Eligibility 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
Sites / Locations
- University Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active drug
Sugar Pill
Arm Description
Ranolazine therapy for three months
sugar pill therapy for three months
Outcomes
Primary Outcome Measures
effective regurgitant orifice by echocardiography
proximal isovelocity surface area by echocardiography
Secondary Outcome Measures
Seattle Angina Questionnaire
Rose Dyspnea Scale
Full Information
NCT ID
NCT01979965
First Posted
October 23, 2013
Last Updated
November 7, 2013
Sponsor
University Cardiology
1. Study Identification
Unique Protocol Identification Number
NCT01979965
Brief Title
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
Acronym
REIN-MR
Official Title
Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Cardiology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Mitral Regurgitation
Keywords
Mitral Regurgitation, cardiac resynchronization therapy, ranolazine, maximal medical therapy, ischemic cardiomyopathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active drug
Arm Type
Active Comparator
Arm Description
Ranolazine therapy for three months
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
sugar pill therapy for three months
Intervention Type
Drug
Intervention Name(s)
Ranolazine (Active drug)
Other Intervention Name(s)
Ranexa
Intervention Description
Ranolazine therapy for three months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo therapy for three months
Primary Outcome Measure Information:
Title
effective regurgitant orifice by echocardiography
Time Frame
Day T = 90 days
Title
proximal isovelocity surface area by echocardiography
Time Frame
T = 90 days
Secondary Outcome Measure Information:
Title
Seattle Angina Questionnaire
Time Frame
T = 0 days, and T = 90 days
Title
Rose Dyspnea Scale
Time Frame
T = 0 days, and T= 90 days
Other Pre-specified Outcome Measures:
Title
Adverse Reactions
Time Frame
T = 90 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj Baljepally, MD
Organizational Affiliation
University Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Cardiology
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Links:
URL
http://utcardiology.com
Description
University Cardiology
Learn more about this trial
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
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