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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01721967
Date of registration: 02/11/2012
Prospective Registration: Yes
Primary sponsor: Duke University
Public title: Ranolazine for the Treatment of Chest Pain in HCM Patients RHYME
Scientific title: Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation
Date of first enrolment: November 2012
Target sample size: 14
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01721967
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hypertrophic Cardiomyopathy
Intervention(s)
Drug: Ranolazine
Primary Outcome(s)
Drug Tolerability [Time Frame: 60 days]
Number of Adverse Events Considered Probably or Possibly Related to Study Drug [Time Frame: 60 Days]
QT Interval [Time Frame: 60 Days]
Secondary Outcome(s)
Improvement in Number of Episodes of Angina Per Week [Time Frame: Baseline and 60 Days post treatment]
Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time Frame: 60 days post treatement]
Seattle Angina Questionnaire (SAQ) [Time Frame: 60 Days post treatment]
Secondary ID(s)
3938381
Pro00039302
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Gilead Sciences
Ethics review
Results
Results available: Yes
Date Posted: 18/01/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01721967
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