A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

— RAMP-DCM  

Official title:

Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133911
• Other study ID #: AHFTX-UMCLJ-1
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2014
• Est. completion date: April 2, 2016

Study information

• Verified date: April 2021
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2, 2016
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Drug:
• Ranolazine

Locations

Country	Name	City	State
Slovenia	Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial perfusion	To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.	6 months
Secondary	Excercise capacity	To determine wheather Ranolazine improves patients' excercise capacity, assesed by 6' walk test	1, 3 and 6 months
Secondary	Left ventricular systolic and diastolic function	To determine wheather Ranolazine improves patients' LV systolic and diastolic function, assesed by LVEF, TDI, LV longitudinal strain and strain rate	1, 3 and 6 months
Secondary	Supraventricular and ventricular arrhythmias	To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.	6 months