Assessing quality of life in patients with hypertrophic cardiomyopathy in Japan
Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
This study is trying to see how living with hypertrophic cardiomyopathy affects the daily lives and well-being of patients in Japan compared to people without the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 470 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Minato-ku, Tokyo) |
| Trial ID | NCT06181617 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate health-related quality of life in patients diagnosed with hypertrophic cardiomyopathy (HCM) in Japan. It consists of two phases: the first phase involves qualitative interviews with HCM patients to gather in-depth insights, while the second phase employs quantitative questionnaires to compare the quality of life between HCM patients and a control group from the general population. The study seeks to understand the impact of HCM on daily living and overall well-being.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with either obstructive or non-obstructive hypertrophic cardiomyopathy in Japan.
Not a fit: Patients with other forms of cardiomyopathy or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the quality of life challenges faced by HCM patients, informing better management and treatment strategies.
How similar studies have performed: While there have been studies assessing quality of life in various cardiac conditions, this specific approach focusing on HCM in Japan is relatively novel.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
Minato-ku, Tokyo
- Mebix. Inc — Minato-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.