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| ID | Type | Description | Link |
|---|---|---|---|
| 3938381 | Other Identifier | Duke University |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Experimental | Ranolazine, 500 mg for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| QT Interval | 60 Days | |
| 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. | 60 Days |
| Drug Tolerability | Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Seattle Angina Questionnaire (SAQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Ranolazine, 500 mg for 60 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Ranolazine, 500 mg for 60 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | QT Interval | Posted | Mean | Standard Deviation | msec | 60 Days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine | Ranolazine, 500 mg for 60 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg Weakness | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Wang, MD | Duke University Health System | 919-681-6197 | a.wang@duke.edu |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D002637 | Chest Pain |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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. |
| 60 Days post treatment |
| 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 | 60 days post treatement |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Seattle Angina Questionnaire | The SAQ is a self-report instrument with 19 items that yields five subscale scores: 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. | Mean | Standard Deviation | units on a scale |
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Similarly, the Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire developed to provide a better description of health-related quality of life in patients with heart failure. It quantifies, in a disease-specific fashion, physical limitation, symptoms (frequency, severity and recent change over time), quality of life, social interference and self-efficacy. All categories of questions are scored from 0-100, with higher number indicating better health. | Mean | Standard Deviation | units on a scale |
|
|
| Primary | 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. | Posted | Number | adverse event | 60 Days |
|
|
|
| Primary | Drug Tolerability | Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose | Posted | Number | participants | 60 days |
|
|
|
| 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). | episodes of angina per week was not collected | Posted | Baseline and 60 Days post treatment |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 60 Days post treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 60 days post treatement |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
| dizziness | General disorders |
|
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| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Treatment satisfaction |
|
| Quality of life |
|
| Title | Measurements |
|---|
|
| Symptom burden |
|
| Total symptom score |
|
| Self-efficacy |
|
| Quality of life |
|
| Social limitation |
|
| Overall summary |
|
| Clinical summary |
|