Heart Failure Clinical Trial
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?
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.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | November 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Ardekani MS, Issa M, Green L. Diagnostic and economic impact of heart failure induced mediastinal lymphadenopathy. Int J Cardiol. 2006 Apr 28;109(1):137-8. — View Citation
Cardinale L, Priola AM, Moretti F, Volpicelli G. Effectiveness of chest radiography, lung ultrasound and thoracic computed tomography in the diagnosis of congestive heart failure. World J Radiol. 2014 Jun 28;6(6):230-7. doi: 10.4329/wjr.v6.i6.230. Review. — View Citation
Huang WM, Feng JY, Cheng HM, Chen SZ, Huang CJ, Guo CY, Yu WC, Chen CH, Sung SH. The role of pulmonary function in patients with heart failure and preserved ejection fraction: Looking beyond chronic obstructive pulmonary disease. PLoS One. 2020 Jul 7;15(7):e0235152. doi: 10.1371/journal.pone.0235152. eCollection 2020. — View Citation
Kee K, Naughton MT. Heart failure and the lung. Circ J. 2010 Nov;74(12):2507-16. Epub 2010 Oct 28. Review. — View Citation
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. Erratum in: Eur Heart J. 2021 Oct 14;:. — View Citation
Obokata M, Olson TP, Reddy YNV, Melenovsky V, Kane GC, Borlaug BA. Haemodynamics, dyspnoea, and pulmonary reserve in heart failure with preserved ejection fraction. Eur Heart J. 2018 Aug 7;39(30):2810-2821. doi: 10.1093/eurheartj/ehy268. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | difference in frequency of chest CT abnormalities between patients with HFrEF and HFpEF | 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 | baseline | |
Secondary | Differences in lung function measured in spirometry between patients with HFpEF and HFrEF | Differences in median forced expiratory volume in 1st second (FEV1) and forced volume capacity (FVC) in spirometry between patients with HFpEF and HFrEF | baseline | |
Secondary | Differences in lung function measured by bodypletysmography between patients with HFpEF and HFrEF | Differences in median total lung capacity (TLC) and reserved volume(RV) in body plethysmography between patients with HFpEF and HFrEF | baseline | |
Secondary | Difference in DLCO between patients with HFpEF and HFrEF | Differences in median diffusing capacity of the lungs for carbon monoxide (DLCO) between patients with HFpEF and HFrEF | baseline | |
Secondary | Differences in arterial pO2 and pCO2 between patients with HFpEF and HFrEF | Differences in median arterial pO2 and pCO2 between patients with HFpEF and HFrEF | baseline | |
Secondary | Differences in lung hydration between patients with HFpEF and HFrEF | difference in median B- line score in lung ultrasound between patients with HFpEF and HFrEF | baseline |
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