Heart FailureNCT05191459
Impact of Hear Failure on Lungs in Patients With Heart Failure
An observational study of Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Heart Failure
- How many people
- 61 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic heart failure between 50-90 years old.
Who may be able to join
- Age: 50-90 years old
- Chronic heart failure (NYHA class II-III)
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw
Warsaw, 02-097
About this study
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 :
Read more
- 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.
Read the 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:
- Age: 50-90 years old
- Chronic heart failure (NYHA class II-III)
- Signed informed consent
Exclusion Criteria:
- 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
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:
- echocardiographic examination of the heart
- X-ray and CT of the chest
- spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
- arterial blood gas testing
- assessment of lung hydration in ultrasound
- 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 :
- 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:
- difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
- differences in arterial pO2 and pCO2
- differences in B- line score in lung 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 enable to reduce unnecessary diagnostics in patients with HF in the future.
- Conditions
- Heart Failure
- Keywords
- heart failure, lung function, chest computed tomography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (5)
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
Measured: baseline
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
Measured: baseline
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
Measured: baseline
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
Measured: baseline
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Dąbrowska, Medical University of Warsaw
- Investigators
- Marta Dąbrowska, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191459
- Sponsor's protocol ID
- Lungs in heart failure
- Status last verified
- Aug 2024
- First submitted
- 2 Jan 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24976926Kee 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.
PubMed 21041971Ardekani 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.
PubMed 16574532Obokata 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.
PubMed 29788047Huang 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.
PubMed 32634145McDonagh 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.
PubMed 34447992
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05191459
- Acronym / sponsor ID
- Lungs in heart failure
- Conditions
- Heart Failure
- Keywords
- heart failure, lung function, chest computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Age: 50-90 years old
- Chronic heart failure (NYHA class II-III)
- Signed informed consent
Exclusion Criteria:
- 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
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:
- echocardiographic examination of the heart
- X-ray and CT of the chest
- spirometry, plethysmography, diffusion capacity for carbon monoxide (DLCO)
- arterial blood gas testing
- assessment of lung hydration in ultrasound
- 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 :
- 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:
- difference in pulmonary function test results (FEV1, FVC, TLC, RV, DLCO)
- differences in arterial pO2 and pCO2
- differences in B- line score in lung 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 enable to reduce unnecessary diagnostics in patients with HF in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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%) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic heart failure between 50-90 years old.
Key inclusion criteria (3 listed)
- Age: 50-90 years old
- Chronic heart failure (NYHA class II-III)
- Signed informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference in frequency of chest CT abnormalities between patients with HFrEF and HFpEF
Time frame: 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
5 secondary outcomes
Differences in lung function measured in spirometry between patients with HFpEF and HFrEF
Time frame: baseline
Differences in lung function measured by bodypletysmography between patients with HFpEF and HFrEF
Time frame: baseline
Difference in DLCO between patients with HFpEF and HFrEF
Time frame: baseline
Differences in arterial pO2 and pCO2 between patients with HFpEF and HFrEF
Time frame: baseline
Differences in lung hydration between patients with HFpEF and HFrEF
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 24976926Cardinale 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.
- Background: PubMed 21041971Kee 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.
- Background: PubMed 16574532Ardekani 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.
- Background: PubMed 29788047Obokata 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.
- Background: PubMed 32634145Huang 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.
- Background: PubMed 34447992McDonagh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Dąbrowska principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in frequency of chest CT abnormalities between patients with HFrEF and HFpEF (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191459, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.