Clinical Trial: A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy

Brief Summary: Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. It has been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.

Detailed Summary:

Recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. Ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. The main mechanism of action of Ranolazine is the inhibition of late I(Na) thus decreasing the Ca++ load in the cardiomyocites. Consequently oxygen consumption also decreases. It has also been shown that in patients with stable coronary disease Ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. The aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.

Primary end-point: To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy.

Secondary end-points: To determine wheather Ranolazine improves patients' NYHA functional class, excercise capacity, LV systolic and diastolic function and weather ranolazine affects supraventricular and ventricular arrhythmia occurance/frequency.


Sponsor: University Medical Centre Ljubljana

Current Primary Outcome: Myocardial perfusion [ Time Frame: 6 months ]

To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Excercise capacity [ Time Frame: 1, 3 and 6 months ]
    To determine wheather Ranolazine improves patients' excercise capacity, assesed by 6' walk test
  • Left ventricular systolic and diastolic function [ Time Frame: 1, 3 and 6 months ]
    To determine wheather Ranolazine improves patients' LV systolic and diastolic function, assesed by LVEF, TDI, LV longitudinal strain and strain rate
  • Supraventricular and ventricular arrhythmias [ Time Frame: 6 months ]
    To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.


Original Secondary Outcome: Same as current

Information By: University Medical Centre Ljubljana

Dates:
Date Received: May 6, 2014
Date Started: May 2014
Date Completion: May 2016
Last Updated: May 6, 2014
Last Verified: May 2014