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

Primary Purpose

Dilated Cardiomyopathy

Status
Completed
Phase
Phase 2
Locations
Slovenia
Study Type
Interventional
Intervention
Ranolazine
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Controls

Ranolazine

Arm Description

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.

Outcomes

Primary Outcome Measures

Myocardial perfusion
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
To determine wheather Ranolazine improves patients' excercise capacity, assesed by 6' walk test
Left ventricular systolic and diastolic function
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
To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.

Full Information

First Posted
May 6, 2014
Last Updated
April 27, 2021
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02133911
Brief Title
A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy
Acronym
RAMP-DCM
Official Title
Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (undefined)
Primary Completion Date
December 15, 2015 (Actual)
Study Completion Date
April 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
No Intervention
Arm Title
Ranolazine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Primary Outcome Measure Information:
Title
Myocardial perfusion
Description
To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Excercise capacity
Description
To determine wheather Ranolazine improves patients' excercise capacity, assesed by 6' walk test
Time Frame
1, 3 and 6 months
Title
Left ventricular systolic and diastolic function
Description
To determine wheather Ranolazine improves patients' LV systolic and diastolic function, assesed by LVEF, TDI, LV longitudinal strain and strain rate
Time Frame
1, 3 and 6 months
Title
Supraventricular and ventricular arrhythmias
Description
To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Poglajen, MD, PhD
Organizational Affiliation
Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bojan Vrtovec, MD, PhD
Organizational Affiliation
Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

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A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

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