Clinical trial NCT02133911: A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy
Official title: Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dilated Cardiomyopathy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Myocardial perfusion
timeFrame: 6 months
Secondary outcomes:
measure: Excercise capacity
timeFrame: 1, 3 and 6 months
measure: Left ventricular systolic and diastolic function
timeFrame: 1, 3 and 6 months
measure: Supraventricular and ventricular arrhythmias
timeFrame: 6 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia
Study officials:
affiliation: Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia
name: Gregor Poglajen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia
name: Bojan Vrtovec, MD, PhD
role: STUDY_DIRECTOR
References: