Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 1:36 PM
Study NCT ID:
NCT05191459
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2022-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Hear Failure on Lungs in Patients With Heart Failure
Sponsor:
Medical University of Warsaw
Organization:
Study Overview
Official Title:
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?
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 :
1. echocardiography
2. chest X-ray and CT
3. assessment of lung hydration in ultrasound
4. spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
5. arterial blood gas analysis
6. 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:
1. difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
2. differences in arterial pO2 and pCO2
3. differences in B- line scores in ultrasound
4. 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.
Eighty four patients diagnosed with HF will be included (42 with HFrEF and 42 with HFpEF) and the following tests will be performed :
1. echocardiography
2. chest X-ray and CT
3. assessment of lung hydration in ultrasound
4. spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
5. arterial blood gas analysis
6. 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:
1. difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
2. differences in arterial pO2 and pCO2
3. differences in B- line scores in ultrasound
4. 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.
Detailed Description:
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:
1. Age: 50-90 years old
2. Chronic heart failure (NYHA class II-III)
3. Signed informed consent
Exclusion Criteria:
1. No consent to the study
2. Age: \<50 or \>90 years old
3. Any chronic pulmonary diseases diagnosed before
4. Acute respiratory infection 14 days before enrollment (fever ≥38°C and at least one additional symptoms of infection)
5. Acute kidney injury or chronic kidney failure (stage 4 or 5)
6. Acute hepatic failure
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 = 0.05, beta = 0.20) assuming that abnormal findings in chest CT will be present in 60% of patients with HFrEF and in 30% of subjects with HFpEF.
Included patients will be examined by:
1. echocardiographic examination of the heart
2. X-ray and CT of the chest
3. spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
4. arterial blood gas testing
5. assessment of lung hydration in ultrasound
6. peripheral blood collection In patients with abnormal, suspected changes in the lungs revealed in the chest CT bronchoscopy and endobronchial ultrasound (EBUS) will be considered.
The primary outcome :
1\. 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:
1. difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
2. differences in arterial pO2 and pCO2
3. differences in B- line score in lung ultrasound
4. 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 enable to reduce unnecessary diagnostics in patients with HF in the future.
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:
1. Age: 50-90 years old
2. Chronic heart failure (NYHA class II-III)
3. Signed informed consent
Exclusion Criteria:
1. No consent to the study
2. Age: \<50 or \>90 years old
3. Any chronic pulmonary diseases diagnosed before
4. Acute respiratory infection 14 days before enrollment (fever ≥38°C and at least one additional symptoms of infection)
5. Acute kidney injury or chronic kidney failure (stage 4 or 5)
6. Acute hepatic failure
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 = 0.05, beta = 0.20) assuming that abnormal findings in chest CT will be present in 60% of patients with HFrEF and in 30% of subjects with HFpEF.
Included patients will be examined by:
1. echocardiographic examination of the heart
2. X-ray and CT of the chest
3. spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
4. arterial blood gas testing
5. assessment of lung hydration in ultrasound
6. peripheral blood collection In patients with abnormal, suspected changes in the lungs revealed in the chest CT bronchoscopy and endobronchial ultrasound (EBUS) will be considered.
The primary outcome :
1\. 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:
1. difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
2. differences in arterial pO2 and pCO2
3. differences in B- line score in lung ultrasound
4. 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 enable to reduce unnecessary diagnostics in patients with HF in the future.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: