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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Hypertrophic Cardiomyopathy

Treatments: Other: Quality of life assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT06181617

CV027-1141

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

149 participants in 3 patient groups

Participants diagnosed with non-obstructive hypertrophic cardiomyopathy

Treatment:

Other: Quality of life assessment

Participants diagnosed with obstructive hypertrophic cardiomyopathy

Treatment:

Other: Quality of life assessment

Control group

Treatment:

Other: Quality of life assessment