Ranolazine for the Treatment of Chest Pain in HCM Patients

Study Overview
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Brief Summary
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The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).

Official Title
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Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Drug: Ranolazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Left Ventricle wall thickness >/= 15mm in the absence of other condition causing hypertrophy Baseline Angina/Shortness of Breath Frequency of > 2 episodes per week Willing to provide informed consent Exclusion Criteria: Severe stenotic valvular disease Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion Significant (>60% stenosis) coronary artery disease Acute coronary syndrome within 30 days Severe heart failure defined as LV systolic dysfunction with Ejection Fraction <40% or NYHA class 4 symptoms Severe renal impairment (glomerular filtration rate, <30 mL/min/1.73 m2) Moderate-severe hepatic impairment (Child-Pugh classes B and C) Hospitalization for cardiac reason within 3 months of enrollment Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors Active myocarditis, pericarditis, or restrictive cardiomyopathy Non-cardiac terminal illness with expected survival less than 6 months Women who are of childbearing potential Inability to perform or adhere to study protocol

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranolazine<br>Ranolazine, 500 mg for 60 days | Drug: Ranolazine<br> <br> * Other names: Ranexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT Interval |  | 60 Days | 
| Number of Adverse Events Considered Probably or Possibly Related to Study Drug | Number of events that are considered probably or possibly related to study drug. | 60 Days | 
| Drug Tolerability | Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Number of Episodes of Angina Per Week | Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week). | Baseline and 60 Days post treatment | 
| Seattle Angina Questionnaire (SAQ) | The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. | 60 Days post treatment | 
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established | 60 days post treatement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest pain, dyspnea