Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Primary composite endpoin
研究概览
简要总结
Study aim is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.
详细描述
Study aim of Investigation "Heart Failure with Preserved Ejection Fraction in Patients with Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis" (HIPSTER) is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.
It is assumed that newly diagnosed HFpEF will occur in at least 6% (COPD PRIORITY data) of cases, and, the presence of HFpEF will negatively affect both the manifestations of the disease and the outcomes and prognosis
During the study it is planned to:
- Perform a retrospective analysis of patient records, determine the frequency of intracardiac hemodynamic disorders, corresponding with the criteria for HFpEF and compare them with the diagnosis in clinical records.
- Identify the patients with previously undiagnosed HFpEF among patients with COPD, and evaluate the frequency of cardiorespiratory comorbidity.
- Examine the general clinical and biochemical blood test parameters in the study groups (as part of a routine in-patient examination).
- Evaluate echocardiography parameters in the study groups (as part of a routine protocol + epicardial adipose tissue thickness (EAT), E/e', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension (EDD).
- Compare spirometry and body plethysmography parameters in the groups depending on the presence of HFpEF criteria.
- Compare the functional status (Six-Minute Walk Test, 6MWT) in the study groups.
- Evaluate patient's vital status after 12 months, information about hospitalizations and their reasons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified diagnosis of COPD;
- •Patients hospitalized with COPD;
- •Citizenship of the Russian Federation;
- •Patients aged 50 to 70 years;
- •Patient consent to participate in the study.
排除标准
- •Lack of Russian Federaion citizenship;
- •Patient's refusal to participate in the study;
- •Any chronic diseases, other than COPD, that affect the prognosis, in the acute and/or decompensated stage;
- •Mental disorders.
研究组 & 干预措施
Patients with Сhronic Obstructive Pulmonary Disease
Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.
干预措施: Echocardiography (Diagnostic Test)
Patients with Сhronic Obstructive Pulmonary Disease
Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.
干预措施: Spirometry (Diagnostic Test)
Patients with Сhronic Obstructive Pulmonary Disease
Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.
干预措施: Body plethysmography (Diagnostic Test)
Patients with Сhronic Obstructive Pulmonary Disease
Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.
干预措施: 6-Minute Walk Test (6MWT) (Diagnostic Test)
Patients with Сhronic Obstructive Pulmonary Disease
Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.
干预措施: laboratory biomarker analysis (Diagnostic Test)
结局指标
主要结局
Primary composite endpoin
时间窗: 1 year
Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE)
次要结局
未报告次要终点