Ranolazine for the Treatment of Chest Pain in HCM Patients

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Gilead Sciences
• Treatments: Ranolazine

Criteria

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