Real-world Patient Reported Outcomes Among Patients Treated With Camzyos

Bristol-Myers Squibb118 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

118

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

MavacamtenDRUG

As prescribed by treating physician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Analysis Group Inc.

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Participant Hypertrophic Cardiomyopathy symptoms as assessed by Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ v2,0 - 7-day recall version)

Time frame: 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)

Time frame: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

Participant mavacamten treatment status

Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96

Other pharmacological and surgical treatments for obstructive hypertrophic cardiomyopathy (HCM)

Time frame: 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

Time frame: 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)

Time frame: Weeks 2, 4, 8, 12, 24, 30, 48, 72, and 96

Participant septal reduction therapy

Time frame: Baseline and weeks 12, 30, 48 and 96

Participant major injury or surgery since previous survey

Time frame: 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

Time frame: Baseline and weeks 4, 12, 30, 48, 72 and 96

Central Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Data from ClinicalTrials.gov

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