Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
REIN-MR
Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 8, 2013
November 1, 2013
6 months
October 23, 2013
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
effective regurgitant orifice by echocardiography
Day T = 90 days
proximal isovelocity surface area by echocardiography
T = 90 days
Secondary Outcomes (2)
Seattle Angina Questionnaire
T = 0 days, and T = 90 days
Rose Dyspnea Scale
T = 0 days, and T= 90 days
Other Outcomes (1)
Adverse Reactions
T = 90 day
Study Arms (2)
Active drug
ACTIVE COMPARATORRanolazine therapy for three months
Sugar Pill
PLACEBO COMPARATORsugar pill therapy for three months
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Cardiology
Knoxville, Tennessee, 37920, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raj Baljepally, MD
University Cardiology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2013
First Posted
November 8, 2013
Study Start
November 1, 2013
Primary Completion
May 1, 2014
Study Completion
September 1, 2014
Last Updated
November 8, 2013
Record last verified: 2013-11