Ranolazine for the Treatment of Chest Pain in HCM Patients (RHYME)

Duke University

Status and phase: Completed; Phase 4

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: Ranolazine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01721967

Pro00039302

3938381 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Ranolazine

Experimental group

Description:

Ranolazine, 500 mg for 60 days

Treatment:

Drug: Ranolazine