A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan

Study Overview
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Brief Summary
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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.

Official Title
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Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan

Conditions
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Hypertrophic Cardiomyopathy

Intervention / Treatment
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* Other: Quality of life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - hypertrophic cardiomyopathy group Participants diagnosed with non-obstructive or obstructive HCM in Japan Participants aged ≥18 years of age Participants who have been attending outpatient visits for HCM and who are referred to the study by the physician treating HCM Participants with HCM who are diagnosed as New York Heart Association (NYHA) functional classification 2-3 at enrolment Participants experiencing burden in their daily lives because of HCM (self-reported) Inclusion Criteria - control group Participants aged ≥18 years of age Individuals from the general population who are enrolled in 3H Clinical Trial's consumer panel Exclusion Criteria - hypertrophic cardiomyopathy group Participants who have ever been diagnosed with dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy Participants who have previously participated or are currently participating in another clinical trial (not including observational studies) Exclusion Criteria - control group Participants who have ever been diagnosed with non-obstructive or obstructive HCM Participants who have ever been diagnosed with either dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants diagnosed with non-obstructive hypertrophic cardiomyopathy<br> | Other: Quality of life assessment<br>* Quality of life assessment<br>|
| Participants diagnosed with obstructive hypertrophic cardiomyopathy<br> | Other: Quality of life assessment<br>* Quality of life assessment<br>|
| Control group<br> | Other: Quality of life assessment<br>* Quality of life assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 |