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

NCT ID: NCT06181617

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-06

Study Completion Date

2025-05-16

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.

Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants diagnosed with non-obstructive hypertrophic cardiomyopathy

Quality of life assessment

Intervention Type OTHER

Quality of life assessment

Participants diagnosed with obstructive hypertrophic cardiomyopathy

Quality of life assessment

Intervention Type OTHER

Quality of life assessment

Control group

Quality of life assessment

Intervention Type OTHER

Quality of life assessment

Interventions

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Quality of life assessment

Quality of life assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)


* Participants aged ≥18 years of age
* Individuals from the general population who are enrolled in 3H Clinical Trial's consumer panel

Exclusion Criteria

* 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)


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Minato-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 40641461 (View on PubMed)

Related Links

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Other Identifiers

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CV027-1141

Identifier Type: -

Identifier Source: org_study_id

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