Ranolazine for the Treatment of Chest Pain in HCM Patients

Overview

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).

Full Title of Study: “Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Supportive Care
  • Masking: None (Open Label)
• Study Primary Completion Date: November 2015

Interventions

• Drug: Ranolazine

Arms, Groups and Cohorts

• Experimental: Ranolazine
  • Ranolazine, 500 mg for 60 days

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

• Improvement in Number of Episodes of Angina Per Week
  • Time Frame: 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).
• Seattle Angina Questionnaire (SAQ)
  • Time Frame: 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)
  • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Duke University
• Collaborator
  • Gilead Sciences
• Provider of Information About this Clinical Study
  • Sponsor