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临床试验/NCT07168655
NCT07168655已完成不适用

Real-World Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Mavacamten - a Single-Center Descriptive Study

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2023年2月21日最近更新:
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
163
试验地点
1
主要终点
Participant age

研究概览

简要总结

The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US

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

入选标准

  • Age ≥ 18 years at index date
  • Prescription of mavacamten for the treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM)
  • ≥ 4 weeks of follow-up after prescription of mavacamten

排除标准

  • Data collection as part of a clinical trial during the study period
  • Current participation in a myosin inhibitor clinical trial

研究组 & 干预措施

Participants prescribed mavacamten treatment

干预措施: Mavacamten (Drug)

结局指标

主要结局

Participant age

时间窗: Baseline

Participant gender

时间窗: Baseline

Participant race

时间窗: Baseline

Participant ethnicity

时间窗: Baseline

Participant insurance coverage

时间窗: Baseline

Participant heart rate

时间窗: Baseline

Participant genotype

时间窗: Baseline

Participant family history

时间窗: Baseline

Participant echocardiogram measurements

时间窗: Baseline

Participant comorbidities

时间窗: Baseline

Mavacamten index dose prescribed

时间窗: Baseline

Participant Body Mass Index

时间窗: Baseline

Participant blood pressure

时间窗: Baseline

Participant New York Heart Association (NYHA) functional class

时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

Participant echocardiogram measurements: Left ventricular outflow tract (LVOT) gradient results at rest, Valsalva and post-exercise (if available)

时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

Participant echocardiogram measurements: Left ventricular ejection fraction (LVEF) percentage

时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

Participant echocardiogram measurements: Maximum left ventricular wall thickness

时间窗: Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks

Participant New York Functional Class classification

时间窗: Baseline

Participant hypertrophic cardiomyopathy (HCM) treatment history

时间窗: Baseline

Participant obstructive hypertrophic cardiomyopathy (oHCM) symptoms (syncope, shortness of breath, fatigue, exercise intolerance, palpitations)

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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