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Completed

NCT Number: NCT06181617

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

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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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Minato-ku, Tokyo, 1050001, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Quality of Life Assessment

Other

Quality of life assessment

Primary outcomes

  1. Participant age

    Time frame: Baseline

  2. Participant sex

    Time frame: Baseline

  3. Participant height

    Time frame: Baseline

  4. Participant weight

    Time frame: Baseline

  5. Participant smoking status

    Time frame: Baseline

  6. Participant drinking status

    Time frame: Baseline

  7. Participant employment status

    Time frame: Baseline

  8. Family members co-residing with participant

    Time frame: Baseline

  9. Participant comorbidities

    Time frame: Baseline

  10. Participant mental disorders under current medical treatment

    Time frame: Baseline

  11. Time from first diagnosis of mental disorders

    Time frame: Baseline

  12. Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM

    Time frame: Baseline

  13. Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM

    Time frame: Baseline

  14. New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy

    Time frame: Baseline

  15. History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy

    Time frame: Baseline

    Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies

  16. Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy

    Time frame: Baseline

  17. Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM

    Time frame: Baseline

  18. Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire

    Time frame: Baseline

    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.

  19. Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)

    Time frame: Baseline

    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.

  20. Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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