Overview
A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy
Status:
Completed
Completed
Trial end date:
2016-04-02
2016-04-02
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Medical Centre LjubljanaTreatments:
Ranolazine
Criteria
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