Real-World Camzyos Patient Reported OutcoMes Through PAtient SurveyS in Hypertrophic CardioMyopathy (COMPASS-HCM): A Prospective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years of age.
- •Participants who are prescribed mavacamten for obstructive hypertrophic cardiomyopathy
- •Provided informed consent to participate in the study
排除标准
- •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
研究组 & 干预措施
Mavacamten
Adult participants with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten
干预措施: Mavacamten (Drug)
结局指标
主要结局
Participant physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, QoL, and social limitations as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
时间窗: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant mavacamten treatment status
时间窗: Weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant major injury or surgery since previous survey
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Baseline and weeks 2, 4, 8, 12, 24, 30, 48, 60, 72, 84 and 96
Participant septal reduction therapy
时间窗: Baseline and weeks 12, 30, 48 and 96
Participant medical history
时间窗: Baseline
Participant change in symptom severity as assessed by Patient Global Impression of Change (PGI-C)
时间窗: 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
时间窗: Baseline and weeks 4, 12, 30, 48, 72 and 96
次要结局
未报告次要终点