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

April 27, 2021 updated by: Gregor Poglajen, University Medical Centre Ljubljana

Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Ranexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 15, 2015

Study Completion (Actual)

April 2, 2016

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHFTX-UMCLJ-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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