NCT06338202已完成不适用
Real-World Effectiveness of MAVacamtEN in Canada (MAVEN): A Retrospective Physician Survey of Patient Charts
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2024年6月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation
研究概览
简要总结
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients who have initiated mavacamten, as part of routine clinical care, through the Bristol Myers Squibb CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
- •Adult patient (≥18 years of age or as defined per local province/territory) at Index Date (first prescribed dose of mavacamten).
- •Patient has been diagnosed with symptomatic oHCM of New York Heart Association (NYHA) class II to III at the time of mavacamten initiation.
排除标准
- •In the 6 weeks prior to baseline (i.e., Index Date; date of first prescribed dose of mavacamten), patient has received any cardiac myosin inhibitor (including mavacamten) for oHCM or any other medical condition as part of a clinical trial.
研究组 & 干预措施
Patients treated with mavacamten
Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care
干预措施: Mavacamten (Drug)
结局指标
主要结局
Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation
时间窗: Up to 1.5 years
* Proportion of patients in each New York Heart Association (NYHA) functional class following mavacamten treatment initiation * Proportion of patients with a reduction of ≥1 New York Heart Association (NYHA) functional class following mavacamten treatment initiation
次要结局
- Obstructive hypertrophic cardiomyopathy (oHCM) disease duration(Baseline)
- Duration of treatment prior to mavacamten discontinuation(Up to 1.5 years)
- Functional assessment schedule(Up to 1.5 years)
- Age(Baseline)
- Proportion of patients in each New York Heart Association (NYHA) functional class II and III(Baseline)
- Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation(Up to 1.5 years)
- Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation(Up to 1.5 years)
- Ethnicity(Baseline)
- Employment status(Baseline)
- Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient(Baseline)
- Left ventricular ejection fraction by 2D echocardiogram (LVEFb)(Baseline)
- Proportion of patients who discontinued mavacamten(Up to 1.5 years)
- Reason for discontinuing mavacamten treatment(Up to 1.5 years)
- Sex at birth(Baseline)
- Body mass index (BMI)(Baseline)
- Mavacamten dose regimen(Up to 1.5 years)
- Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation(Up to 1.5 years)
- Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation(Up to 1.5 years)
研究者
研究点 (1)
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