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
- 5
- 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
研究组 & 干预措施
Subjects with CV risk factors
Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.
干预措施: NYHA assessment (Diagnostic Test)
Subjects with CV risk factors
Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.
干预措施: Serum NT-proBNP concentration (Procedure)
Subjects with CV risk factors
Subjects with 2 or more CV risk factors will be identified. Cardiovascular risk factors include hypertension, dyslipidemia, obesity, vascular disease, diabetes mellitus, chronic kidney disease, arrhythmia requiring therapy, moderate to severe valvular disease, history of alcohol abuse, smoking, cancer chemotherapy, or thoracic radiotherapy, and abnormal findings in the most recent ECG or thoracic X-ray.
干预措施: Transthoracic Ecocardiogram (Diagnostic Test)
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
- Percentage of subjects with CV risk factors among participating countries(5 months)
- Percentage of subjects with CV risk factos(5 months)
- Comparison of number of subjects diagnosed with HF stage C(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)