Ranolazine for the Treatment of Chest Pain in HCM Patients

Hypertrophic Cardiomyopathy Clinical Trial

— RHYME  

Official title:

Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721967
• Other study ID #: Pro00039302
• Secondary ID: 3938381
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2012
• Last updated: May 11, 2016
• Start date: November 2012
• Est. completion date: May 2016

Study information

• Verified date: December 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• Ranolazine

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Ranolazine with regard to QT interval		60 Days	No
Primary	Safety of Ranolazine with regard to adverse events		60 Days	No
Primary	Safety of Ranolazine with regard to drug tolerability		60 days	No
Secondary	Improvement in number of episodes of angina per week	Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).	Baseline and 60 Days post treatment	No
Secondary	Improvement in dyspnea	Efficacy of ranolazine in HCM patients with respect to improvements in dyspnea.	Baseline and 60 Days post treatment	No
Secondary	Improvement in quality of life	Efficacy of ranolazine in HCM patients with respect to improvement in quality of life evaluation with the Seattle Angina Questionnaire (SAQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ).	Baseline and 60 Days post treatment	No