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

Bristol-Myers Squibb149 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

149

Conditions

Hypertrophic Cardiomyopathy

Interventions

Quality of life assessmentOTHER

Quality of life assessment

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Local Institution - 0001

Minato-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Participant age

Time frame: Baseline

Participant sex

Time frame: Baseline

Participant height

Time frame: Baseline

Participant weight

Time frame: Baseline

Participant smoking status

Time frame: Baseline

Participant drinking status

Time frame: Baseline

Participant employment status

Time frame: Baseline

Family members co-residing with participant

Time frame: Baseline

Participant comorbidities

Time frame: Baseline

Participant mental disorders under current medical treatment

Time frame: Baseline

Time from first diagnosis of mental disorders

Time frame: Baseline

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

Time frame: Baseline

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

Time frame: Baseline

Data from ClinicalTrials.gov

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