Impact of Hear Failure on Lungs in Patients With Heart Failure

NCT05191459 | Completed

• 1 other identifier: Lungs in heart failure
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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. 1.echocardiography
2. 2.chest X-ray and CT
3. 3.assessment of lung hydration in ultrasound
4. 4.spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
5. 5.arterial blood gas analysis
6. 6.peripheral blood collection
7. 7.difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
8. 8.differences in arterial pO2 and pCO2
9. 9.differences in B- line scores in ultrasound
10. 10.differences in concentration of blood biomarkers (troponin, CRP, NTproBNP, IL-6, TNF-α, sST2, Gal-3, GDF-15)

Conditions

Heart Failure

Keywords

heart failure; lung function; chest computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Differences in lung function measured in spirometry 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

• Differences in lung hydration between patients with HFpEF and HFrEF

  baseline

Study Arms (2)

Heart failure and preserved ejection fraction

42 patients 50-90 years with preserved ejection fraction (EF ≥50%)

Heart failure and reduced ejection fraction

42 patients 50-90 years with reduced ejection fraction ((EF≤40%)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic heart failure between 50-90 years old.

You may qualify if:

• Age: 50-90 years old
• Chronic heart failure (NYHA class II-III)
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Related Publications (6)

• 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.

  PMID: 24976926 BACKGROUND

• Kee K, Naughton MT. Heart failure and the lung. Circ J. 2010 Nov;74(12):2507-16. doi: 10.1253/circj.cj-10-0869. Epub 2010 Oct 28.

  PMID: 21041971 BACKGROUND

• 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. doi: 10.1016/j.ijcard.2005.04.011. No abstract available.

  PMID: 16574532 BACKGROUND

• 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.

  PMID: 29788047 BACKGROUND

• 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.

  PMID: 32634145 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm 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. No abstract available.

  PMID: 34447992 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marta Dąbrowska

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: January 13, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)