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This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed with non-obstructive hypertrophic cardiomyopathy |
| ||
| Participants diagnosed with obstructive hypertrophic cardiomyopathy |
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| Control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life assessment | Other | Quality of life assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant age | Baseline | |
| Participant sex | Baseline | |
| Participant height | Baseline | |
| Participant weight | Baseline | |
| Participant smoking status | Baseline | |
| Participant drinking status | Baseline | |
| Participant employment status | Baseline | |
| Family members co-residing with participant | Baseline | |
| Participant comorbidities | Baseline | |
| Participant mental disorders under current medical treatment | Baseline | |
| Time from first diagnosis of mental disorders | Baseline | |
| Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM |
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Inclusion Criteria - hypertrophic cardiomyopathy group
Inclusion Criteria - control group
Exclusion Criteria - hypertrophic cardiomyopathy group
Exclusion Criteria - control group
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Study population will include adult patients who are diagnosed with hypertrophic cardiomyopathy in Japan, as well as a control group that do not have hypertrophic cardiomyopathy
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Minato-ku | Tokyo | 1050001 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40641461 | Derived | Maekawa Y, Ikeda Y, Torigoe M, Shimoura K, Suo S, Takeda R, Kitaoka H. Qualitative analysis of experiences, burdens, and needs among patients with hypertrophic cardiomyopathy in Japan. Future Cardiol. 2025 Aug;21(10):759-768. doi: 10.1080/14796678.2025.2526279. Epub 2025 Jul 11. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| Baseline |
| Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM | Baseline |
| New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy | Baseline |
| History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy | Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies | Baseline |
| Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy | Baseline |
| Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM | Baseline |
| Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire | EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The total score ranges from -0.025 to 1, and higher scores reflect better health status. | Baseline |
| Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS) | HADS is an anxiety and depression assessment scale consisting of seven items (rated 0, 1, 2, or 3) related to anxiety (subscale A) and seven other items related to depression (subscale D). The total score ranges from 0 to 14, and higher scores reflect a worse health status. | Baseline |
| Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | The KCCQ is a 23-item questionnaire developed to assess HRQoL in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL, social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status. | Baseline |
| FDA Safety Alerts and Recalls | View source |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |