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Ranolazine for the Treatment of Chest Pain in HCM Patients (RHYME)

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertrophic Cardiomyopathy focused on measuring chest pain, dyspnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranolazine

Arm Description

Ranolazine, 500 mg for 60 days

Outcomes

Primary Outcome Measures

QT Interval
Number of Adverse Events Considered Probably or Possibly Related to Study Drug
Number of events that are considered probably or possibly related to study drug.
Drug Tolerability
Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose

Secondary Outcome Measures

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).
Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established

Full Information

First Posted
November 2, 2012
Last Updated
January 19, 2017
Sponsor
Duke University
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01721967
Brief Title
Ranolazine for the Treatment of Chest Pain in HCM Patients
Acronym
RHYME
Official Title
Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
chest pain, dyspnea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Experimental
Arm Description
Ranolazine, 500 mg for 60 days
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Primary Outcome Measure Information:
Title
QT Interval
Time Frame
60 Days
Title
Number of Adverse Events Considered Probably or Possibly Related to Study Drug
Description
Number of events that are considered probably or possibly related to study drug.
Time Frame
60 Days
Title
Drug Tolerability
Description
Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Improvement in Number of Episodes of Angina Per Week
Description
Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).
Time Frame
Baseline and 60 Days post treatment
Title
Seattle Angina Questionnaire (SAQ)
Description
The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.
Time Frame
60 Days post treatment
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established
Time Frame
60 days post treatement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Ranolazine for the Treatment of Chest Pain in HCM Patients

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