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 :
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:
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.
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.
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:
Exclusion Criteria:
Power analysis and sample size calculations indicated that a sample size of 84 subjects would provide 80% statistical power to detect significant differences between the two groups (alpha
Included patients will be examined by:
The primary outcome :
The secondary outcomes:
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 enable to reduce unnecessary diagnostics in patients with HF in the future.
Condition | Heart Failure |
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Clinical Study Identifier | NCT05191459 |
Sponsor | Medical University of Warsaw |
Last Modified on | 5 June 2022 |
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