Clinical trial NCT06551129: Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
Official title: Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Hypertrophic Cardiomyopathy
Keywords: Obstructive Hypertrophic cardiomyopathy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-13
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants in the United States diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)
timeFrame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
measure: Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
timeFrame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
measure: Participant mavacamten treatment status
timeFrame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
measure: Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)
timeFrame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
measure: Participant symptom severity as assessed by self-assessed New York Heart Association (SA-NYHA) functional class
timeFrame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
measure: Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C)
timeFrame: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96
measure: Participant septal reduction therapy
timeFrame: Baseline and weeks 12, 30, 48 and 96
measure: Participant major injury or surgery since previous survey
timeFrame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
measure: Participant survey response on experience with CAMZYOS Risk Evaluation and Mitigation Strategy program (REMS) Program
timeFrame: Baseline and weeks 4, 12, 30, 48, 72 and 96
measure: Participant medical history
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Analysis Group Inc.
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: