Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

Recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: Mavacamten

• Registration Number: NCT06551129
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Participants ≥18 years of age.
• Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
• Provided informed consent to participate in the study

Exclusion Criteria

• Previously or currently enrolled in clinical trials for any cardiac myosin inhibitors
• Treated for >7 days with mavacamten by the day of completing the baseline survey
• Enrolled in any clinical trials at the time of or within the six-month period prior to the screening
• Had heart attack requiring coronary artery bypass grafting within the three-month period prior to the screening
• Had stroke or transient ischemic attack within the six-month period prior to the screening
• Had moderate-to-severe lung disease which impacted the ability to perform daily activities of living and ability to breathe
• Had major lung (thoracic) or heart (cardiac) surgery within the six-month period prior to the screening
• Scheduled for a major surgery for the next three months, such as joint surgeries including hip replacement, abdominal surgeries, lung surgeries, heart surgeries, eye surgeries, brain surgeries, and any other major surgeries that require general anesthesia and at least an overnight hospital stay
• Hospitalized requiring an overnight stay at the time of or within the two-week period prior to the screening

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mavacamten	Mavacamten	Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten

Primary Outcome Measures

Name	Time	Method
Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)	Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant mavacamten treatment status	Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant major injury or surgery since previous survey	Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)	Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)	Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class	Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant septal reduction therapy	Baseline and weeks 12, 30, 48 and 96
Participant medical history	Baseline
Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C)	Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96
Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program	Baseline and weeks 4, 12, 30, 48, 72 and 96

Trial Locations

Locations (1)

Analysis Group Inc.; 🇺🇸 Boston, Massachusetts, United States