Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

Phase 4

• Conditions: Ischemic Mitral Regurgitation
• Interventions: Drug: Ranolazine (Active drug); Drug: Placebo

• Registration Number: NCT01979965
• Lead Sponsor: University Cardiology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-23
• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-07
• Last Update Submitted: 2013-11-07
• Study First Posted: 2013-11-08
• Last Update Posted: 2013-11-08
• Primary Completion: 2014-05
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active drug	Ranolazine (Active drug)	Ranolazine therapy for three months
Sugar Pill	Placebo	sugar pill therapy for three months

Primary Outcome Measures

Name	Time	Method
effective regurgitant orifice by echocardiography	Day T = 90 days
proximal isovelocity surface area by echocardiography	T = 90 days

Secondary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire	T = 0 days, and T = 90 days
Rose Dyspnea Scale	T = 0 days, and T= 90 days

Trial Locations

Locations (1)

University Cardiology; 🇺🇸 Knoxville, Tennessee, United States