Ranolazine in Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiomyopathy, Chest Pain, Dyspnea

Intervention / Treatment
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* Drug: Ranexa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Anginal chest pain or dyspnea Documentation of non treatable or optimally treated coronary artery disease Ejection Fraction of less than or equal to 40% Exclusion Criteria: Less than 18 years of age Pregnant or breast feeding Patients with non ischemic cardiomyopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |