Real-world Patient Reported Outcomes Among Patients Treated With Camzyos (COMPASS-HCM)

Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Intervention / Treatment: Drug: Mavacamten

• Study Type: Observational
• Enrollment (Estimated): 118

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02199
      • Recruiting
      • Analysis Group Inc.
      • Contact: Min Yang, Site 0001; Email: COMPASS@analysisgroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants in the United States diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mavacamten; Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten	Drug: Mavacamten; As prescribed by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participant medical history	Baseline
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
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
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 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 septal reduction therapy	Baseline and weeks 12, 30, 48 and 96
Participant major injury or surgery since previous survey	Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive Hypertrophic cardiomyopathy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
• Other Study ID Numbers: CV027-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No