Status:
COMPLETED
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18+ years
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 quali...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2025
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT06181617
Start Date
December 6 2023
End Date
May 16 2025
Last Update
July 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0001
Minato-ku, Tokyo, Japan, 1050001