A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy (RAMP-DCM)
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|ClinicalTrials.gov Identifier: NCT02133911|
Recruitment Status : Unknown
Verified May 2014 by Gregor Poglajen, University Medical Centre Ljubljana.
Recruitment status was: Recruiting
First Posted : May 8, 2014
Last Update Posted : May 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy||Drug: Ranolazine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||May 2016|
|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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|