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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Gregor Poglajen, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT02133911
First received: May 6, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dilated Cardiomyopathy
Drug: Ranolazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Myocardial perfusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.


Secondary Outcome Measures:
  • Excercise capacity [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.


Estimated Enrollment: 70
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Controls
Experimental: 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.
Drug: Ranolazine
Other Name: Ranexa

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02133911

Contacts
Contact: Gregor Poglajen, MD, PhD +38615228671 gregor.poglajen@kclj.si
Contact: Bojan Vrtovec, MD, PhD bojan.vrtovec@kclj.si

Locations
Slovenia
Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia Recruiting
Ljubljana, Slovenia, 1000
Contact: Gregor Poglajen, MD, PhD    +38615221148    kokftx@gmail.com   
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         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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
  More Information

No publications provided

Responsible Party: Gregor Poglajen, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02133911     History of Changes
Other Study ID Numbers: AHFTX-UMCLJ-1
Study First Received: May 6, 2014
Last Updated: May 6, 2014
Health Authority: Slovenia: Republic of Slovenia National Medical Ethics Committee

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014