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Trial record 18 of 130 for:    "Dilated cardiomyopathy"

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

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ClinicalTrials.gov Identifier: NCT02133911
Recruitment Status : Unknown
Verified May 2014 by Gregor Poglajen, University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: Ranolazine Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Myocardial perfusion [ Time Frame: 6 months ]
    To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.


Secondary Outcome Measures :
  1. Excercise capacity [ Time Frame: 1, 3 and 6 months ]
    To determine wheather Ranolazine improves patients' excercise capacity, assesed by 6' walk test

  2. Left ventricular systolic and diastolic function [ Time Frame: 1, 3 and 6 months ]
    To determine wheather Ranolazine improves patients' LV systolic and diastolic function, assesed by LVEF, TDI, LV longitudinal strain and strain rate

  3. Supraventricular and ventricular arrhythmias [ Time Frame: 6 months ]
    To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gregor Poglajen, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02133911     History of Changes
Other Study ID Numbers: AHFTX-UMCLJ-1
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action