Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01979965
NCT01979965
Unknown
Phase 4

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

University Cardiology1 site in 1 country50 target enrollmentNovember 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsIschemic Mitral Regurgitation
InterventionsRanolazine (Active drug)Placebo
DrugsRanolazine (Active drug)Placebo

Overview

Phase
Phase 4
Intervention
Ranolazine (Active drug)
Conditions
Ischemic Mitral Regurgitation
Sponsor
University Cardiology
Enrollment
50
Locations
1
Primary Endpoint
effective regurgitant orifice by echocardiography
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
September 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Cardiology
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Active drug

Ranolazine therapy for three months

Intervention: Ranolazine (Active drug)

Sugar Pill

sugar pill therapy for three months

Intervention: Placebo

Outcomes

Primary Outcomes

effective regurgitant orifice by echocardiography

Time Frame: Day T = 90 days

proximal isovelocity surface area by echocardiography

Time Frame: T = 90 days

Secondary Outcomes

  • Seattle Angina Questionnaire(T = 0 days, and T = 90 days)
  • Rose Dyspnea Scale(T = 0 days, and T= 90 days)

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
Effect of Significant Ischemic Mitral Regurgitation on the Outcome of ST Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary InterventionIschemic Mitral Regurgitation
NCT04106648Assiut University134
Completed
Phase 3
Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans (MVTWA) Patients With LV DysfunctionSudden Cardiac DeathVentricular Arrythmias
NCT00998218Aspirus Heart and Vascular Institute-Research and Education7
Unknown
Not Applicable
Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 SpectroscopyAnginaHeart Disease
NCT01804543Westside Medical Associates of Los Angeles30
Completed
Phase 2
Ranolazine Mediated PVC Reduction in Ischemic Heart DiseaseVentricular Premature ComplexesMyocardial Ischemia
NCT02360397Kent Hospital, Rhode Island6
Terminated
Not Applicable
Effect of Ranolazine on Echocardiographic Indices of Diastolic DysfunctionRanolazineDiastolic Heart FailureTissue Doppler UltrasoundEchocardiography
NCT00574756University of California, San Diego14