A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

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Brief Title

A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Official Title

Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Myocardial perfusion

Secondary Outcome

 Excercise capacity

Condition

Dilated Cardiomyopathy

Intervention

Ranolazine

Study Arms / Comparison Groups

 Controls
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

May 2014

Completion Date

May 2016

Primary Completion Date

December 2015

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Gregor Poglajen, MD, PhD, +38615228671, [email protected]

Location Countries

Slovenia

Location Countries

Slovenia

Administrative Informations


NCT ID

NCT02133911

Organization ID

AHFTX-UMCLJ-1


Responsible Party

Principal Investigator

Study Sponsor

University Medical Centre Ljubljana


Study Sponsor

Gregor Poglajen, MD, PhD, Principal Investigator, Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia


Verification Date

May 2014