NTproBNP based screening to understand the prevalence of Heart Failure in high-risk population: the SECURE-HF study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 92
研究概览
简要总结
Heart failure (HF) is a significant global public health challenge, with an estimated prevalence of over 64 million people worldwide. The estimated prevalence and incidence rates of heart failure in India due to coronary heart disease, hypertension, obesity, diabetes and rheumatic heart disease ranges from 1.3 to 4.6 million, with an annual incidence of 491, 600–1.8 million. The global burden of HF cases worldwide almost doubled from 33.5 million in 1990 to 64.3 million in 2017, while the age-standardized prevalence rate of HF showed a slow downward trend, indicating that population ageing and growth mostly accounted for the absolute increase in the number of HF cases.
SECURE-HF is a multicenter, prospective, observational study which will be conducted at multiple centres across India. The study is designed to estimate the prevalence of heart failure (HF) and “heart stress” in a high-risk outpatient population using age stratified NT-proBNP thresholds recommended by the Heart Failure Association (HFA) of the European Society of Cardiology.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients satisfying all the following criteria will be included in the study: Male or female patients aged greater than equal to 30 years at the time of screening.
- •Presence or known case of at least one of the following risk factors associated with early or preclinical heart failure: Hypertension Diabetes Mellitus Ischemic Heart Disease (IHD) / Coronary Artery Disease(CAD) Chronic Kidney Disease (CKD) Atrial Fibrillation Chronic Obstructive Pulmonary Disease (COPD) Obesity / Obstructive Sleep Apnoea Cardiomyopathy Hyperthyroidism History of Oncotherapy (chemotherapy or radiotherapy) Structural Heart Disease (e.g., left ventricular hypertrophy, valvular abnormalities) Willing and able to provide informed consent and comply with study procedures.
排除标准
- •Patients satisfying any of the following criteria will be excluded from the study: Confirmed diagnosis of heart failure (Stage C or D) as per 2022 AHA/ACC/HFSA classification, recorded at any time prior to the index date.
- •Acute Coronary Syndrome (ACS) within 1 month prior to screening.
- •Hospitalization or major surgical procedure within the past 1 month.
研究者
Dr Chintan Khandhedia
Sun Pharma Laboratories Limited