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

April 17, 2024 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Japan
      • Tokyo, Japan
        • Recruiting
        • Mebix, Inc
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1050001
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Other: Quality of life assessment
Quality of life assessment
Participants diagnosed with non-obstructive hypertrophic cardiomyopathy
Other: Quality of life assessment
Quality of life assessment
Participants diagnosed with obstructive hypertrophic cardiomyopathy
Other: Quality of life assessment
Quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant age
Time Frame: Baseline
Baseline
Participant sex
Time Frame: Baseline
Baseline
Participant employment status
Time Frame: Baseline
Baseline
Participant height
Time Frame: Baseline
Baseline
Participant weight
Time Frame: Baseline
Baseline
Participant smoking status
Time Frame: Baseline
Baseline
Participant drinking status
Time Frame: Baseline
Baseline
Family members co-residing with participant
Time Frame: Baseline
Baseline
Participant comorbidities
Time Frame: Baseline
Baseline
Participant mental disorders under current medical treatment
Time Frame: Baseline
Baseline
Time from first diagnosis of mental disorders
Time Frame: Baseline
Baseline
Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Time Frame: Baseline
Baseline
Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Time Frame: Baseline
Baseline
New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy
Time Frame: Baseline
Baseline
History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy
Time Frame: Baseline
Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies
Baseline
Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy
Time Frame: Baseline
Baseline
Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM
Time Frame: Baseline
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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