Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

Ischemic Mitral Regurgitation Clinical Trial

— REIN-MR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01979965
• Other study ID #: IN-US-259-0173
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 23, 2013
• Last updated: November 7, 2013
• Start date: November 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2013
• Source: University Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ischemia
• Ischemic Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Drug:
• Ranolazine (Active drug)
Ranolazine therapy for three months
• Placebo
Placebo therapy for three months

Locations

Country	Name	City	State
United States	University Cardiology	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University Cardiology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Reactions		T = 90 day	Yes
Primary	effective regurgitant orifice by echocardiography		Day T = 90 days	No
Primary	proximal isovelocity surface area by echocardiography		T = 90 days	No
Secondary	Seattle Angina Questionnaire		T = 0 days, and T = 90 days	No
Secondary	Rose Dyspnea Scale		T = 0 days, and T= 90 days	No

External Links

•   University Cardiology