Ranolazine for the Treatment of Chest Pain in HCM Patients

Phase 4

Completed

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ranolazine	Ranolazine	Ranolazine, 500 mg for 60 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire (SAQ)	60 Days post treatment	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.
Kansas City Cardiomyopathy Questionnaire (KCCQ)	60 days post treatement	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
Improvement in Number of Episodes of Angina Per Week	Baseline and 60 Days post treatment	Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).