Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 6
- 主要终点
- Number of Cases of HF stage C
研究概览
简要总结
This is a pilot, multicenter, real-world, single-visit, low risk, phase IV interventional study to efficiently identify new cases of heart failure (HF) Stage C in subjects who are at risk of cardiovascular (CV) disease in high-volume ambulatory primary care settings in 3 countries in Central America.
详细描述
Subjects with 2 or more CV risk factors will be identified and will undergo an NYHA score assessment. If the NYHA score is ≥ II, the serum NT-proBNP concentration will be determined on-site on the same day. If the serum NT proBNP concentration is ≥ 125 pg/mL, the subject will be referred to a country specific central echocardiography laboratory for a transthoracic echocardiogram to measure the left ventricular ejection fraction (LVEF) and relevant structural heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 61 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the study
- •Male or female patients aged > 60 years at the time of informed consent
- •Presence of at least 2 or more of the following risk factors for HF (CV risk factors already diagnosed prior to study visit according to the usual medical practice criteria and listed in the medical chart):
- •Hypertension
- •Dyslipidemia
- •Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease
- •Type 1 or 2 diabetes mellitus
- •Chronic kidney disease
- •Arrhythmia requiring therapy
- •Moderate to severe valvular disease
- •History of alcohol abuse,
- •History of smoking,
- •History of cancer chemotherapy, or
- •i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray
- •Attendance at a primary care consultation for reasons not related to HF
排除标准
- •Previous diagnosis of HF
- •Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months)
- •Echocardiogram performed within the 12 months before the primary care consultation
结局指标
主要结局
Number of Cases of HF stage C
时间窗: 5 months
Proportion of subjects with HF Stage C among those with 2 or more CV risk factors
次要结局
- Comparison of number of subjects diagnosed with HF stage C(5 months)
- Percentage of subjects with CV risk factos(5 months)
- Percentage of subjects with CV risk factors among participating countries(5 months)
- Ratio of subjects with each listed CV risk factor between subjects with and without HF Stage C(5 months)
- Incidence of equality of HF Stage C among participating countries(5 months)
- Mean NT-proBNP levels among subjects diagnosed with HF Stage C versus subjects with no HF(5 months)