Hypertrophic Cardiomyopathy: A Burden of Illness Study In India- Retrospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The primary objective is to assess the clinical burden (patient’s demographic characteristics, HCM diagnosis, HCM symptoms, NYHA classification, treatment and monitoring, medical history, and fatal CV complications) of HCM (including patients with obstructive HCM and non-obstructive HCM) in India using electronic health records (EHRs) and patient questionnaires
研究概览
简要总结
Hypertrophic cardiomyopathy HCM is a genetic heart disease, inherited in an autosomal dominant pattern and accounts for 88 percentage of the world population. HCM is one of the most common phenotypes of cardiomyopathy. HCM is defined as a disease state in which morphologic expression is confined solely to the heart. It is characterized predominantly by left ventricular hypertrophy LVH in the absence of another cardiac or systemic or metabolic disease capable of producing the magnitude of hypertrophy evident in a given patient and for which a disease causing sarcomere or sarcomere related variant is identified or genetic etiology remains unresolved.
In India the disease burden of patients with HCM is not well understood. There are very few publications articles that capture the burden of HCM in India and no comprehensive account or publication exists at a national level. Therefore this study aims to generate evidence on prevalence and mortality from literature clinical burden health care resource utilization HCRU and health related quality of life HRQoL especially for patients with obstructive HCM and non obstructive HCM in India. The data derived from this study could be used for development of economic modeling such as cost effectiveness analysis budget impact models etc.
This study provides the opportunity to collect data out of controlled conditions. The study findings can be utilized for better understanding of the burden of HCM in real world clinical practice. Although the sample size of included population is small this study will set a platform for further research on a wider scale with longer follow ups to provide more robust data on burden of illness of HCM in Indian population.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18 years or more with established diagnosis of HCM at study enrollment (cross sectional survey) or at index date (retrospective).
- •Patients or their caregiver (authorized representative) who are willing and able to sign ICF (cross-sectional survey).
- •Patients with a minimum of 12 months follow-up after index date (retrospective).
排除标准
- •Patients with no EHRs data available (retrospective).
- •Patients with clinical conditions that mimic HCM (such as amyloidosis, hemochromatosis, sarcoidosis, Fabry disease, etc).
结局指标
主要结局
The primary objective is to assess the clinical burden (patient’s demographic characteristics, HCM diagnosis, HCM symptoms, NYHA classification, treatment and monitoring, medical history, and fatal CV complications) of HCM (including patients with obstructive HCM and non-obstructive HCM) in India using electronic health records (EHRs) and patient questionnaires
时间窗: 1 year ( 52 Weeks)
次要结局
- 1. To assess annualized health care resource utilization (HCRU) & associated costs of HCM (including patients with obstructive HCM & non-obstructive HCM) in India using patient, health care professional (HCP), & procurement staff questionnaires.(1 year (52 Weeks))
- 2. To assess health related quality of life (HRQoL) in patients with HCM (including patients with obstructive HCM & non-obstructive HCM) in India using patient questionnaires.(1 year ( 52 Weeks))
研究者
Dr Abhinav Keshwani
Bristol-Myers Squibb India Pvt. Ltd.
