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

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Completed
CT.gov ID
NCT02133911
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
23.1
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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
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
Actual Enrollment :
10 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 1, 2014
Actual Primary Completion Date :
Dec 15, 2015
Actual Study Completion Date :
Apr 2, 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 Names:
  • Ranexa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Myocardial perfusion [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 [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 [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 [6 months]

      To determine wheather Ranolazine affects the occurence of supraventricular and ventricular arrhythmia occurance/frequency using 24 holter monitor.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia Ljubljana Slovenia 1000

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gregor Poglajen, MD, PhD, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT02133911
    Other Study ID Numbers:
    • AHFTX-UMCLJ-1
    First Posted:
    May 8, 2014
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Cardiomyopathies
    Cardiomyopathy, Dilated
    Ranolazine

    Study Results

    No Results Posted as of Apr 28, 2021