Hypertrophic Cardiomyopathy Clinical Trial

Ranolazine for the Treatment of Chest Pain in HCM Patients

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).

View Eligibility Criteria

Eligibility 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

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 4

Estimated Enrollment:

14

Study ID:

NCT01721967

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 4

Estimated Enrollment:

14

Study ID:

NCT01721967

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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