Ranolazine for the Treatment of Chest Pain in HCM Patients

NCT ID: NCT01721967

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-05-31

Brief 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).

Conditions

Hypertrophic Cardiomyopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ranolazine

Ranolazine, 500 mg for 60 days

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

Interventions

Ranolazine

Intervention Type: DRUG

Other Intervention Names

Ranexa

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

3938381

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00039302

Identifier Type: -

Identifier Source: org_study_id