Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

Ranolazine Effects on Ischemic Mitral Regurgitation Severity in Patients With Cardiac Resynchronization Therapy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01979965

Acronym

REIN-MR

Enrollment

Registered

2013-11-08

Start date

2013-11-30

Completion date

2014-09-30

Last updated

2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Mitral Regurgitation

Keywords

Mitral Regurgitation, cardiac resynchronization therapy, ranolazine, maximal medical therapy, ischemic cardiomyopathy

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.

Interventions

DRUGRanolazine (Active drug)

Ranolazine therapy for three months

DRUGPlacebo

Placebo therapy for three months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
effective regurgitant orifice by echocardiography	Day T = 90 days
proximal isovelocity surface area by echocardiography	T = 90 days

Secondary

Measure	Time frame
Seattle Angina Questionnaire	T = 0 days, and T = 90 days
Rose Dyspnea Scale	T = 0 days, and T= 90 days

Other

Measure	Time frame
Adverse Reactions	T = 90 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026