A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

NCT02133911 | Completed Phase 2 DMC

• 1 other identifier: AHFTX-UMCLJ-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Myocardial perfusion

  To determine wheather Ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy assesed by myocardial nuclear imaging.

  6 months

Secondary Outcomes (3)

• Excercise capacity

  1, 3 and 6 months

• Left ventricular systolic and diastolic function

  1, 3 and 6 months

• Supraventricular and ventricular arrhythmias

  6 months

Study Arms (2)

Controls

NO INTERVENTION

Ranolazine

EXPERIMENTAL

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

Interventions

Ranolazine DRUG

Also known as: Ranexa

Ranolazine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

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

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gregor Poglajen, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Bojan Vrtovec, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: May 1, 2014
• Primary Completion: December 15, 2015
• Study Completion: April 2, 2016
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

SL (1)