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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Duke University Medical Center
Durham, North Carolina, United States
QT Interval
Time frame: 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.
Time frame: 60 Days
Drug Tolerability
Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose
Time frame: 60 days
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).
Time frame: 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.
Time frame: 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
Time frame: 60 days post treatement
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