Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Hospitalization for exacerbation of HF
研究概览
简要总结
Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.
详细描述
Heart failure with preserved ejection fraction (HFpEF) is a serious condition with an unfavorable prognosis.
The investigators aimed to evaluate in patients with HFpEF:
- the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves;
- the prognostic significance of clinical parameters (sex, age, NYHA class, extra-cardiac diseases, therapy);
- the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis;
- to identify independent predictors of adverse prognosis of HFpEF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and data informed consent;
- •New York Heart Association (NYHA) class II-III heart failure;
- •Left ventricular ejection fraction > 50%;
- •Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.
排除标准
- •Evidence of myocardial ischemia during stress echocardiography;
- •Significant lesions of the main coronary arteries;
- •Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
- •Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
- •Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
- •Primary pulmonary artery hypertension;
- •Significant left-sided structural valve disease;
- •Anemia (Hb < 100 g/L);
- •Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI);
- •Non-cardiac conditions that complicate/exclude participation in the study;
- •Exacerbation of heart failure less than 3 months prior to study entry.
研究组 & 干预措施
with primary outcome
Patients with HFpEF who experienced primary outcome (were hospitalized for HF or died)
without primary outcome
Patients with HFpEF who survived without hospitalization for HF
结局指标
主要结局
Hospitalization for exacerbation of HF
时间窗: From enrollment to August 2026
All-cause mortality
时间窗: From enrollment to August 2026
Hospitalization for exacerbation of HF
时间窗: From enrollment to August 2025
All-cause mortality
时间窗: From enrollment to August 2025
次要结局
未报告次要终点
研究者
Anastasiia Filatova, MD, PhD
principal investigator, MD
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation