Clinical trial NCT06181617: A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
Official title: Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Participant age
timeFrame: Baseline
measure: Participant sex
timeFrame: Baseline
measure: Participant height
timeFrame: Baseline
measure: Participant weight
timeFrame: Baseline
measure: Participant smoking status
timeFrame: Baseline
measure: Participant drinking status
timeFrame: Baseline
measure: Participant employment status
timeFrame: Baseline
measure: Family members co-residing with participant
timeFrame: Baseline
measure: Participant comorbidities
timeFrame: Baseline
measure: Participant mental disorders under current medical treatment
timeFrame: Baseline
measure: Time from first diagnosis of mental disorders
timeFrame: Baseline
measure: Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
timeFrame: Baseline
measure: Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
timeFrame: Baseline
measure: New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy
timeFrame: Baseline
measure: History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy
timeFrame: Baseline
measure: Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy
timeFrame: Baseline
measure: Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM
timeFrame: Baseline
measure: Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
timeFrame: Baseline
measure: Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)
timeFrame: Baseline
measure: Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Mebix. Inc
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: