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

Launched by BRISTOL-MYERS SQUIBB · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how hypertrophic cardiomyopathy (HCM) affects the quality of life for patients in Japan. HCM is a heart condition where the heart muscle becomes thick, which can make it harder for the heart to pump blood. The study has two parts: the first part involves talking with patients to understand their experiences and challenges, while the second part uses questionnaires to gather more information, comparing HCM patients with people who do not have the condition.

To participate, you need to be at least 18 years old and diagnosed with either obstructive or non-obstructive HCM. You should also be experiencing some difficulties in your daily life due to HCM. If you don’t have HCM but are part of a general population panel, you may be eligible for the control group. Participants will have the chance to share their experiences and help researchers learn more about how HCM impacts daily living. The study is currently recruiting participants, and your involvement could contribute to better understanding and treatment of this condition.

Gender

ALL

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)