Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To identify pulmonary vascular disease in post/long-COVID-19 patients as a cause of dyspnea/exercise limitation and to differentiate it from other causes of dyspnea
The aim is to identify pulmonary vascular disease in post/long-COVID-19 patients as a cause of dyspnea/exercise limitation and to differentiate it from other causes of dyspnea (muscular, left cardiac, psychological, deconditioning-related causes) by investigating ventilation-perfusion (V/Q) mismatch and (exercise-induced) pulmonary hypertension (PH) or right heart dysfunction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary vascular dysfunction | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of gas exchange under different inhaled oxygen concentrations | Non-invasive estimation of ventilation/perfusion (V/Q) mismatch | At the time of presentation (on day 1) |
| Spiroergometric capacity- maximal oxygen uptake (VO2max; ml/min/kg) | Determination of exercise capacity by cardiopulmonary exercise testing (CPET) | At the time of presentation (on day 1) |
| Echocardiographic right heart parameters - pulmonary arterial systolic pressure (PASP; mmHg) | Echocardiographic determination of right heart parameters under rest and during exercise | At the time of presentation (on day 1) |
| Echocardiographic right heart parameters - Tricuspid annular plane systolic excursion (TAPSE; mm) | Echocardiographic determination of right heart parameters under rest and during exercise | At the time of presentation (on day 1) |
| Echocardiographic right heart parameters - right ventricular (RV) end-ventricular volume (EDV; ml) | Echocardiographic determination of right heart parameters under rest and during exercise | At the time of presentation (on day 1) |
| Echocardiographic right heart - right volume (RV) end-systolic volume (ESV; ml) | Echocardiographic determination of right heart parameters under rest and during exercise | At the time of presentation (on day 1) |
| Echocardiographic right heart - right ventricular longitudinal global strain (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Left heart parameters - (E/e' ratio) | Determination of left heart parameters during rest and exercise | At the time of presentation (on day 1) |
| Left heart parameters - left ventricular ejection fraction (%) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with a post-COVID-19 syndrome or a long-COVID-19 syndrome at least 3 months after SARS-CoV-2 infection (symptomatic or asymptomatic); Patients at least 3 months after a SARS-CoV-2 infection (symptomatic or asymptomatic) without post/long-COVID-19.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Natascha Sommer, PD | Cardiopulmonary Institute (CPI), University of Giessen and Marburg Lung Center (UGMLC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Natascha Sommer | Giessen | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33753937 | Background | 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. | |
| 34526314 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| pulmonary vascular function | Other | 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. |
|
Echocardiographic determination of right heart parameters under rest and during exercise |
| At the time of presentation (on day 1) |
| Dyspnoea Index | Determination of dyspnea and functional capacity a questionaire measure of shortness of breath for determining exertion levels | At the time of presentation (on day 1) |
| Invasive hemodynamics - pulmonary vascular resistance (PVR; WU) | Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup) | At the time of presentation (on day 1) |
| Invasive hemodynamics - cardiac Index (CI; l/min/m2) | Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup) | At the time of presentation (on day 1) |
Determination of left heart parameters during rest and exercise
| At the time of presentation (on day 1) |
| Pulmonary vascular function | Increase of echocardiographically estimated systolic pulmonary arterial pressure during inhalation of hypoxic gas | At the time of presentation (on day 1) |
| Airway Impedance | Determination of airway impedance by oscillometry | At the time of presentation (on day 1) |
| Peripheral blood mononuclear cells | Determination of characteristics of peripheral immune cells by fluorescence activated cell sorter (FACS) and functional assays | At the time of presentation (on day 1) |
| Shunt measurement | Shunt measurement by contrast-enhanced echocardiography (optional) | At the time of presentation (on day 1) |
| Ventilation/Perfusion mismatch | Determination of V/Q mismatch using the gold standard multiple inert gas elimination technique (MIGET) (only in RHC subgroup) | At the time of presentation (on day 1) |
| Static and dynamic lung function parameters - vital capacity (VC; L) | Determination of lung function by body plethysmography at rest | At the time of presentation (on day 1) |
| Static and dynamic lung function parameters - forced expiratory volume in 1 s (FEV1; L) | Determination of lung function by body plethysmography at rest | At the time of presentation (on day 1) |
| Static and dynamic lung function parameters - diffusion capacity (DLCO; %) | Determination of lung function by body plethysmography at rest | At the time of presentation (on day 1) |
| Static and dynamic lung function parameters - diffusion coefficient (DLCO/VA; %) | Determination of lung function by body plethysmography at rest | At the time of presentation (on day 1) |
| Background |
| 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. |
| 33827250 | Background | 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. |
| 34897638 | Background | 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. |
| 19497725 | Background | 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. |
| 12698242 | Background | 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. |
| 23430364 | Background | 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. |
| 33140085 | Background | 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. |
| 19670105 | Background | 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. |
| 18421437 | Background | 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. |
| 33483331 | Background | 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. |
| 33303539 | Background | 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. |
| 34027514 | Background | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |