A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy (RAMP-DCM)

University Medical Centre Ljubljana

Status and phase: Completed; Phase 2

Conditions: Dilated Cardiomyopathy

Treatments: Drug: Ranolazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02133911

AHFTX-UMCLJ-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Controls

No Intervention group

Ranolazine

Experimental group

Description:

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.

Treatment:

Drug: Ranolazine