Dilated Cardiomyopathy
Conditions
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 description
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.
Interventions
DRUGRanolazine
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* established diagnosis of non-ischemic dilated cardiomyopathy * EF \< 35% * NYHA f.c. II - IV * Optimal medical management \> 6 months * Age \< 75 years and \> 18 years
Exclusion criteria
* known hypersensitivity to the medication * age \> 75 years or \< 18 years * EF \> 35% * renal insufficiency (GF \< 30) * liver dysfunction (liver tests \> 3x the upper normal limit)) * LQT syndrome * drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.) * dementia * active hemathological or malignant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion | 6 months | To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excercise capacity | 1, 3 and 6 months | To determine wheather Ranolazine improves patients' excercise capacity, assesed by 6' walk test |
| Left ventricular systolic and diastolic function | 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 | 6 months | To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor. |
Countries
Slovenia
Outcome results
None listed