Ranolazine in Ischemic Cardiomyopathy

Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study

Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.

Study Overview

• Status: Completed
• Conditions: Chest Pain; Dyspnea; Cardiomyopathy
• Intervention / Treatment: Drug: Ranexa; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
2. Anginal chest pain or dyspnea
3. Documentation of non treatable or optimally treated coronary artery disease
4. Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

1. Less than 18 years of age
2. Pregnant or breast feeding
3. Patients with non ischemic cardiomyopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ranolazine; 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug: Ranexa; 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.; Other Names: Ranolazine
Placebo Comparator: Placebo; 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug: Placebo; 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anginal Frequency	Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.	12 weeks
Quality of Life	Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.	12 weeks
Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)	RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.	12 weeks

Collaborators and Investigators

• Sponsor: Midwest Cardiovascular Research Foundation
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Nicolas W Shammas, MD, Midwest Cardiovascular Research Foundation

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Signs and Symptoms, Respiratory; Chest Pain; Cardiomyopathies; Dyspnea; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Sodium Channel Blockers; Ranolazine
• Other Study ID Numbers: IN-US-259-D032