A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2016-04-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dilated Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Ranolazine

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.

Group Type EXPERIMENTAL

Ranolazine

Intervention Type DRUG

Interventions

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Ranolazine

Intervention Type DRUG

Other Intervention Names

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Ranexa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No