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

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181617
• Other study ID #: CV027-1141
• Status: Recruiting
• Start date: December 6, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: June 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Other:
• Quality of life assessment
Quality of life assessment

Locations

Country	Name	City	State
Japan	Mebix. Inc	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant age		Baseline
Primary	Participant sex		Baseline
Primary	Participant height		Baseline
Primary	Participant weight		Baseline
Primary	Participant smoking status		Baseline
Primary	Participant drinking status		Baseline
Primary	Participant employment status		Baseline
Primary	Family members co-residing with participant		Baseline
Primary	Participant comorbidities		Baseline
Primary	Participant mental disorders under current medical treatment		Baseline
Primary	Time from first diagnosis of mental disorders		Baseline
Primary	Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM		Baseline
Primary	Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM		Baseline
Primary	New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy		Baseline
Primary	History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy	Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies	Baseline
Primary	Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy		Baseline
Primary	Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM		Baseline
Primary	Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire	EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The total score ranges from -0.025 to 1, and higher scores reflect better health status.	Baseline
Primary	Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)	HADS is an anxiety and depression assessment scale consisting of seven items (rated 0, 1, 2, or 3) related to anxiety (subscale A) and seven other items related to depression (subscale D). The total score ranges from 0 to 14, and higher scores reflect a worse health status.	Baseline
Primary	Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ)	The KCCQ is a 23-item questionnaire developed to assess HRQoL in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL, social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status.	Baseline

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls