Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After Coronavirus Disease (COVID-19)
NCT ID: NCT05374577
Last Updated: 2025-09-04
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2022-04-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with a suspected diagnosis of post/long-COVID-19
Patients with a suspected post-COVID-19 syndrome or a long-COVID-19 syndrome at least 3 months after severe acute respiratory syndrome coronavirus(CoV) type 2 (SARS-CoV-2) infection (symptomatic or asymptomatic)
pulmonary vascular dysfunction
Right ventricular function determined by echocardiography at rest and during exercise (non-invasive estimation of ventilation-perfusion mismatch), systemic endothelial function, left heart function, and plasma levels of vasoactive biomarkers compared with clinical parameters of dyspnea and exercise capacity. Further examinations will be performed in patients with still unclear cause of persistent shortness of breath after 3 months of follow-up (subgroup RHC)
Patients without post/long-COVID-19 Syndrome
Patients at least 3 months after a SARS-CoV-2 infection (symptomatic or asymptomatic) without post/long-COVID-19.
pulmonary vascular function
Right ventricular function determined by echocardiography at rest and during exercise (non-invasive estimation of ventilation-perfusion mismatch), systemic endothelial function, and plasma levels of vasoactive biomarkers compared with clinical parameters of dyspnea and exercise capacity.
Interventions
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pulmonary vascular dysfunction
Right ventricular function determined by echocardiography at rest and during exercise (non-invasive estimation of ventilation-perfusion mismatch), systemic endothelial function, left heart function, and plasma levels of vasoactive biomarkers compared with clinical parameters of dyspnea and exercise capacity. Further examinations will be performed in patients with still unclear cause of persistent shortness of breath after 3 months of follow-up (subgroup RHC)
pulmonary vascular function
Right ventricular function determined by echocardiography at rest and during exercise (non-invasive estimation of ventilation-perfusion mismatch), systemic endothelial function, and plasma levels of vasoactive biomarkers compared with clinical parameters of dyspnea and exercise capacity.
Eligibility Criteria
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Inclusion Criteria
* Patients at least 3 and not longer than 18 months after a SARS-CoV-2 infection without post/long-COVID-19 syndrome who present to our post-infection outpatient clinic for follow-up
Exclusion Criteria
* Severe underlying chronic pulmonary, cardiac, or systemic disease (e.g., Chronic obstructive pulmonary disease (COPD), severe heart failure, neuromuscular disease) that was diagnosed prior to acute COVID-19 disease and whose progression appears likely as the cause of dyspnea
* Other non pneumologic causes of dyspnea (e.g., hemoglobin \< 100 g/L)
* Unstable or acute disease (e.g., acute infection, acute renal failure, acute coronary syndrome)
* Inability to perform spiroergometry, including transient orthopedic problems, contraindications to central venous and arterial catheter placement (e.g., severe bleeding tendency).
18 Years
ALL
No
Sponsors
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University of Giessen
OTHER
Responsible Party
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Principal Investigators
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Natascha Sommer, PD
Role: PRINCIPAL_INVESTIGATOR
Cardiopulmonary Institute (CPI), University of Giessen and Marburg Lung Center (UGMLC)
Locations
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Natascha Sommer
Giessen, , Germany
Countries
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References
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Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
Gierhardt M, Pak O, Walmrath D, Seeger W, Grimminger F, Ghofrani HA, Weissmann N, Hecker M, Sommer N. Impairment of hypoxic pulmonary vasoconstriction in acute respiratory distress syndrome. Eur Respir Rev. 2021 Sep 15;30(161):210059. doi: 10.1183/16000617.0059-2021. Print 2021 Sep 30.
Nuzzi V, Castrichini M, Collini V, Roman-Pognuz E, Di Bella S, Luzzati R, Berlot G, Confalonieri M, Merlo M, Stolfo D, Sinagra G. Impaired Right Ventricular Longitudinal Strain Without Pulmonary Hypertension in Patients Who Have Recovered From COVID-19. Circ Cardiovasc Imaging. 2021 Apr;14(4):e012166. doi: 10.1161/CIRCIMAGING.120.012166. Epub 2021 Apr 8. No abstract available.
Rossi R, Coppi F, Monopoli DE, Sgura FA, Arrotti S, Boriani G. Pulmonary arterial hypertension and right ventricular systolic dysfunction in COVID-19 survivors. Cardiol J. 2022;29(1):163-165. doi: 10.5603/CJ.a2021.0159. Epub 2021 Dec 13. No abstract available.
Reichenberger F, Voswinckel R, Schulz R, Mensch O, Ghofrani HA, Olschewski H, Seeger W. Noninvasive detection of early pulmonary vascular dysfunction in scleroderma. Respir Med. 2009 Nov;103(11):1713-8. doi: 10.1016/j.rmed.2009.05.004. Epub 2009 Jun 3.
Kjaergaard S, Rees S, Malczynski J, Nielsen JA, Thorgaard P, Toft E, Andreassen S. Non-invasive estimation of shunt and ventilation-perfusion mismatch. Intensive Care Med. 2003 May;29(5):727-34. doi: 10.1007/s00134-003-1708-0. Epub 2003 Apr 16.
Thomsen LP, Karbing DS, Smith BW, Murley D, Weinreich UM, Kjaergaard S, Toft E, Thorgaard P, Andreassen S, Rees SE. Clinical refinement of the automatic lung parameter estimator (ALPE). J Clin Monit Comput. 2013 Jun;27(3):341-50. doi: 10.1007/s10877-013-9442-9. Epub 2013 Feb 21.
Trinkmann F, Benck U, Halder J, Semmelweis A, Saur J, Borggrefe M, Akin I, Kaden JJ. Automated Noninvasive Central Blood Pressure Measurements by Oscillometric Radial Pulse Wave Analysis: Results of the MEASURE-cBP Validation Studies. Am J Hypertens. 2021 Apr 20;34(4):383-393. doi: 10.1093/ajh/hpaa174.
Winkler J, Hagert-Winkler A, Wirtz H, Hoheisel G. [Modern impulse oscillometry in the spectrum of pulmonary function testing methods]. Pneumologie. 2009 Aug;63(8):461-9. doi: 10.1055/s-0029-1214938. Epub 2009 Aug 7. German.
Wagner PD. The multiple inert gas elimination technique (MIGET). Intensive Care Med. 2008 Jun;34(6):994-1001. doi: 10.1007/s00134-008-1108-6. Epub 2008 Apr 18.
Shah W, Hillman T, Playford ED, Hishmeh L. Managing the long term effects of covid-19: summary of NICE, SIGN, and RCGP rapid guideline. BMJ. 2021 Jan 22;372:n136. doi: 10.1136/bmj.n136. No abstract available.
Sonnweber T, Sahanic S, Pizzini A, Luger A, Schwabl C, Sonnweber B, Kurz K, Koppelstatter S, Haschka D, Petzer V, Boehm A, Aichner M, Tymoszuk P, Lener D, Theurl M, Lorsbach-Kohler A, Tancevski A, Schapfl A, Schaber M, Hilbe R, Nairz M, Puchner B, Huttenberger D, Tschurtschenthaler C, Asshoff M, Peer A, Hartig F, Bellmann R, Joannidis M, Gollmann-Tepekoylu C, Holfeld J, Feuchtner G, Egger A, Hoermann G, Schroll A, Fritsche G, Wildner S, Bellmann-Weiler R, Kirchmair R, Helbok R, Prosch H, Rieder D, Trajanoski Z, Kronenberg F, Woll E, Weiss G, Widmann G, Loffler-Ragg J, Tancevski I. Cardiopulmonary recovery after COVID-19: an observational prospective multicentre trial. Eur Respir J. 2021 Apr 29;57(4):2003481. doi: 10.1183/13993003.03481-2020. Print 2021 Apr.
Augustin M, Schommers P, Stecher M, Dewald F, Gieselmann L, Gruell H, Horn C, Vanshylla K, Cristanziano VD, Osebold L, Roventa M, Riaz T, Tschernoster N, Altmueller J, Rose L, Salomon S, Priesner V, Luers JC, Albus C, Rosenkranz S, Gathof B, Fatkenheuer G, Hallek M, Klein F, Suarez I, Lehmann C. Post-COVID syndrome in non-hospitalised patients with COVID-19: a longitudinal prospective cohort study. Lancet Reg Health Eur. 2021 Jul;6:100122. doi: 10.1016/j.lanepe.2021.100122. Epub 2021 May 18.
Other Identifiers
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KKS-300
Identifier Type: -
Identifier Source: org_study_id
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