A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy (RAMP-DCM)
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy|
- 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.
- 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.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|No Intervention: Controls|
Initial dose is 375 mg bid. After 2 - 4 weeks the dose is increased to 500 mg bid and after another 2-4 weeks to 750 mg bid. In case of side effects the dose of the drug is to be decreased to the highest dose that the patient is still able to tolerate.
Other Name: Ranexa
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02133911
|Contact: Gregor Poglajen, MD, PhDfirstname.lastname@example.org|
|Contact: Bojan Vrtovec, MD, PhDemail@example.com|
|Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia||Recruiting|
|Ljubljana, Slovenia, 1000|
|Contact: Gregor Poglajen, MD, PhD +38615221148 firstname.lastname@example.org|
|Principal Investigator: Gregor Poglajen, MD, PhD|
|Sub-Investigator: Bojan Vrtovec, MD, PhD|
|Sub-Investigator: Borut Jug, MD, PhD|
|Sub-Investigator: Andraž Cerar, MD|
|Sub-Investigator: Mojca Bervar, MD|
|Principal Investigator:||Gregor Poglajen, MD, PhD||Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia|
|Study Director:||Bojan Vrtovec, MD, PhD||Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia|