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

NCT06181617 | Completed

• 1 other identifier: CV027-1141
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (3)

Participants diagnosed with non-obstructive hypertrophic cardiomyopathy

Other: Quality of life assessment

Participants diagnosed with obstructive hypertrophic cardiomyopathy

Other: Quality of life assessment

Control group

Other: Quality of life assessment

Interventions

Quality of life assessment OTHER

Quality of life assessment

Control group; Participants diagnosed with non-obstructive hypertrophic cardiomyopathy; Participants diagnosed with obstructive hypertrophic cardiomyopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Minato-ku, Tokyo, 1050001, Japan

Location

Related Publications (1)

• 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.

  PMID: 40641461 DERIVED

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: December 6, 2023
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)