Are There Any Differences in Occurrence of Lung Changes Associated With the Chronic Heart Failure Between the Patients With Preserved and Reduced Ejection Fraction of Left Ventricle?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- difference in frequency of chest CT abnormalities between patients with HFrEF and HFpEF
研究概览
简要总结
Heart failure (HF) is a common disease, which impacts on other organs. Despite an ongoing progress in knowledge about HF, there are still some uncharted aspects of impact of HF on respiratory system. The aim of the study is to determine whether there are any differences in pulmonary changes assessed in chest CT, chest ultrasound or in pulmonary function tests between patients with HF with decreased (≤40%; HFrEF) and preserved (≥50%; HFpEF) ejection fraction.
Eighty four patients diagnosed with HF will be included (42 with HFrEF and 42 with HFpEF) and the following tests will be performed :
- echocardiography
- chest X-ray and CT
- assessment of lung hydration in ultrasound
- spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
- arterial blood gas analysis
- peripheral blood collection
In patients with abnormal, suspected changes in the lungs diagnosed in the chest CT bronchoscopy and endobronchial ultrasound (EBUS) will be offered.
The primary outcome will be difference in frequency of chest CT abnormalities (ground-glass opacities or interlobular septal thickening or pleural effusion or mediastinal lymphadenopathy) between patients with HFrEF and HFpEF
The secondary outcomes will be:
- difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
- differences in arterial pO2 and pCO2
- differences in B- line scores in ultrasound
- differences in concentration of blood biomarkers (troponin, CRP, NTproBNP, IL-6, TNF-α, sST2, Gal-3, GDF-15)
The results of the study will allow to .better understand the pathomechanisms of the occurrence of lesions in lungs secondary to HF. Thus, it may anable to reduce unnecessary diagnostics in patients with HF in the future.
详细描述
Heart failure (HF) is a global disease, which affects 1-2% adults worldwide. It is believed that 60% of these patients have HF with reduced ejection fraction (EF≤40%; HFrEF), 24% have HF with mildly reduced (EF 41-49%; HFmrEF) and 16% have HF with preserved ejection fraction (EF ≥50%, HFpEF). Despite its high prevalence, there are still many aspects of the disease that are not well recognized yet. One of them is impact of HFpEF on function lungs. Previous studies focused on this topic are scarce and mainly concern patients with advanced HFrEF. It was documented that HFrEF may lead to both lung abnormal changes in chest imaging and lung function tests. It may sometimes lead to unnecessary diagnostic procedures. However, pathophysiology and clinical relevance between heart and lung function in HFpEF patients still need to be elucidated.
Thus the aim of the study is to determine whether pulmonary abnormal findings found both in chest imaging and pulmonary function tests are comparable in patients with HFpEF and HFrEF.
Patients:
The study will include 84 patients (42 with HFrEF and 42 with HFpEF) aged 50-90 years diagnosed with chronic HF (NYHA II/III) in a stable period.
Inclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 50-90 years old
- •Chronic heart failure (NYHA class II-III)
- •Signed informed consent
排除标准
- •No consent to the study
- •Age: <50 or >90 years old
- •Any chronic pulmonary diseases diagnosed before
- •Acute respiratory infection 14 days before enrollment (fever ≥38°C and at least one additional symptoms of infection)
- •Acute kidney injury or chronic kidney failure (stage 4 or 5)
- •Acute hepatic failure
结局指标
主要结局
difference in frequency of chest CT abnormalities between patients with HFrEF and HFpEF
时间窗: baseline
difference in frequency of chest CT abnormalities (ground-glass opacities or interlobular septal thickening or pleural effusion or mediastinal lymphadenopathy) between patients with HFrEF and HFpEF
次要结局
- Differences in lung function measured in spirometry between patients with HFpEF and HFrEF(baseline)
- Differences in lung hydration between patients with HFpEF and HFrEF(baseline)
- Differences in lung function measured by bodypletysmography between patients with HFpEF and HFrEF(baseline)
- Difference in DLCO between patients with HFpEF and HFrEF(baseline)
- Differences in arterial pO2 and pCO2 between patients with HFpEF and HFrEF(baseline)
研究者
Marta Dąbrowska
Principal Investigator
Medical University of Warsaw
