DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction (EMPATHY-HF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- An increased of post-exercise E/e' ratio
研究概览
简要总结
Prevalence of heart failure with preserved ejection fraction (HFpEF) continues to increase in the developed world, likely because of the increasing life expectancy and an increasing number of elderly patients.
Transthoracic echocardiography is essential for the diagnosis of HFpEF according to the current guidelines. The HFA-PEFF and H2FPEF diagnostic algorithms rely on clinical characteristics and echocardiography findings that indicate the presence of diastolic dysfunction.
These diagnostic algorithms are not applicable in remote areas where expert echocardiography cannot be performed due to the absence of modern ultrasound systems and lack of qualified specialists. Therefore, it is important to develop an algorithm to evaluate pre-test probability of HFpEF without echocardiographic markers, so it can be easily used in the primary outpatient care setting by any specialist.
The aim of this study is to find the associations between clinical and epidemiological characteristics and changes of intracardiac hemodynamics in patients with dyspnea and decreased exercise tolerance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)
排除标准
- •Morbid obesity;
- •Any chronic diseases in the stage of exacerbation and / or decompensation;
- •Systemic diseases, cancer;
- •Cardiac arrhythmias: persistent atrial fibrillation or paroxysmal atrial fibrillation with frequent paroxysms;
- •History of myocardial infarction, stroke, heart failure with reduced ejection fraction;
- •Storage diseases, hypertrophic cardiomyopathy, concentric hypertrophy;
- •Congenital and acquired heart defect;
结局指标
主要结局
An increased of post-exercise E/e' ratio
时间窗: during diastolic stress test (baseline)
An increased of post-exercise pulmonary artery systolic pressure (PASP)
时间窗: during diastolic stress test (baseline)
次要结局
未报告次要终点