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

Sponsor

University Cardiology (Other)

Overall Status

Unknown status

CT.gov ID

NCT01979965

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2013

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Active drug

Ranolazine therapy for three months

Drug: Ranolazine (Active drug)

Ranolazine therapy for three months

Other Names:

Ranexa

Placebo Comparator: Sugar Pill

sugar pill therapy for three months

Drug: Placebo

Placebo therapy for three months

Outcome Measures

Primary Outcome Measures

effective regurgitant orifice by echocardiography [Day T = 90 days]
proximal isovelocity surface area by echocardiography [T = 90 days]

Secondary Outcome Measures

Seattle Angina Questionnaire [T = 0 days, and T = 90 days]
Rose Dyspnea Scale [T = 0 days, and T= 90 days]

Other Outcome Measures

Adverse Reactions [T = 90 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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