Phase 4
N=14
Ranolazine for the Treatment of Chest Pain in HCM Patients
Hypertrophic Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT01721967 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: QT Interval — 462.8 msec
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ranolazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY QT Interval |
462.8 | — |
| PRIMARY Number of Adverse Events Considered Probably or Possibly Related to Study Drug |
10 | — |
| PRIMARY Drug Tolerability |
9; 4 | — |
| SECONDARY Improvement in Number of Episodes of Angina Per Week |
— | — |
| SECONDARY Seattle Angina Questionnaire (SAQ) |
61.4; 90.0; 86.0; 90.6; 70.8 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire (KCCQ) |
72; 72.7; 72.2; 75; 73.6; 85.2 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01721967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.