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COVID-19PulmVasCNCT05374577

Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After Coronavirus Disease (COVID-19)

An observational study of COVID-19, run by University of Giessen at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
pulmonary vascular dysfunction and pulmonary vascular function
How many people
200 participants
Where
1 siteGermany
Study dates
15 Apr 2022to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Age ≥ 18 years, patients with a suspected diagnosis of post/long-COVID-19 syndrome who present to our pneumology or infectious disease outpatient clinic or corresponding ward from the start of the study and whose SARS-CoV-2 infection was diagnosed at least 3 and not longer than 18 months prior to presentation
  • 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

Who cannot join

  • Patients who refuse to participate in the study
  • 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).

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Natascha Sommer

    Giessen

Other trials in Germany

About this study

Official title: Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After COVID-19 (PulmVasC)- A Multicenter, Prospective Cohort/Observational Study

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

Read the detailed description

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.

Conditions
COVID-19
Being tested
pulmonary vascular dysfunction, pulmonary vascular function
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pulmonary vascular dysfunctionOther

    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 functionOther

    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.

Study groups in NCT05374577
Study groupRoleWhat they receive
Patients with a suspected diagnosis of post/long-COVID-19Patients 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)
Receives: Other: pulmonary vascular dysfunction
Patients without post/long-COVID-19 SyndromePatients at least 3 months after a SARS-CoV-2 infection (symptomatic or asymptomatic) without post/long-COVID-19.
Receives: Other: pulmonary vascular function

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of gas exchange under different inhaled oxygen concentrations

    Non-invasive estimation of ventilation/perfusion (V/Q) mismatch

    Measured: At the time of presentation (on day 1)

  2. Spiroergometric capacity- maximal oxygen uptake (VO2max; ml/min/kg)

    Determination of exercise capacity by cardiopulmonary exercise testing (CPET)

    Measured: At the time of presentation (on day 1)

  3. Echocardiographic right heart parameters - pulmonary arterial systolic pressure (PASP; mmHg)

    Echocardiographic determination of right heart parameters under rest and during exercise

    Measured: At the time of presentation (on day 1)

  4. Echocardiographic right heart parameters - Tricuspid annular plane systolic excursion (TAPSE; mm)

    Echocardiographic determination of right heart parameters under rest and during exercise

    Measured: At the time of presentation (on day 1)

  5. Echocardiographic right heart parameters - right ventricular (RV) end-ventricular volume (EDV; ml)

    Echocardiographic determination of right heart parameters under rest and during exercise

    Measured: At the time of presentation (on day 1)

  6. Echocardiographic right heart - right volume (RV) end-systolic volume (ESV; ml)

    Echocardiographic determination of right heart parameters under rest and during exercise

    Measured: At the time of presentation (on day 1)

  7. Echocardiographic right heart - right ventricular longitudinal global strain (%)

    Echocardiographic determination of right heart parameters under rest and during exercise

    Measured: At the time of presentation (on day 1)

  8. Dyspnoea Index

    Determination of dyspnea and functional capacity a questionaire measure of shortness of breath for determining exertion levels

    Measured: At the time of presentation (on day 1)

  9. Invasive hemodynamics - pulmonary vascular resistance (PVR; WU)

    Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup)

    Measured: At the time of presentation (on day 1)

  10. Invasive hemodynamics - cardiac Index (CI; l/min/m2)

    Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup)

    Measured: At the time of presentation (on day 1)

Secondary outcomes (11)
  1. Left heart parameters - (E/e' ratio)

    Determination of left heart parameters during rest and exercise

    Measured: At the time of presentation (on day 1)

  2. Left heart parameters - left ventricular ejection fraction (%)

    Determination of left heart parameters during rest and exercise

    Measured: At the time of presentation (on day 1)

  3. Pulmonary vascular function

    Increase of echocardiographically estimated systolic pulmonary arterial pressure during inhalation of hypoxic gas

    Measured: At the time of presentation (on day 1)

  4. Airway Impedance

    Determination of airway impedance by oscillometry

    Measured: At the time of presentation (on day 1)

  5. Peripheral blood mononuclear cells

    Determination of characteristics of peripheral immune cells by fluorescence activated cell sorter (FACS) and functional assays

    Measured: At the time of presentation (on day 1)

  6. Shunt measurement

    Shunt measurement by contrast-enhanced echocardiography (optional)

    Measured: At the time of presentation (on day 1)

  7. Ventilation/Perfusion mismatch

    Determination of V/Q mismatch using the gold standard multiple inert gas elimination technique (MIGET) (only in RHC subgroup)

    Measured: At the time of presentation (on day 1)

  8. Static and dynamic lung function parameters - vital capacity (VC; L)

    Determination of lung function by body plethysmography at rest

    Measured: At the time of presentation (on day 1)

  9. Static and dynamic lung function parameters - forced expiratory volume in 1 s (FEV1; L)

    Determination of lung function by body plethysmography at rest

    Measured: At the time of presentation (on day 1)

  10. Static and dynamic lung function parameters - diffusion capacity (DLCO; %)

    Determination of lung function by body plethysmography at rest

    Measured: At the time of presentation (on day 1)

  11. Static and dynamic lung function parameters - diffusion coefficient (DLCO/VA; %)

    Determination of lung function by body plethysmography at rest

    Measured: At the time of presentation (on day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start15 Apr 2022
  3. Primary completion31 Mar 2025
  4. Study completionDec 2025 (estimated)

Resources

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
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374577
Sponsor's protocol ID
KKS-300
Acronym
PulmVasC
Status last verified
Sep 2025
First submitted
29 Apr 2022
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33753937
  • 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.

    PubMed 34526314
  • 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.

    PubMed 33827250
  • 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.

    PubMed 34897638
  • 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.

    PubMed 19497725
  • 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.

    PubMed 12698242
  • 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.

    PubMed 23430364
  • 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.

    PubMed 33140085
  • 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.

    PubMed 19670105
  • 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.

    PubMed 18421437
  • 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.

    PubMed 33483331
  • 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.

    PubMed 33303539
  • 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.

    PubMed 34027514

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by University of Giessen at 1 site in Germany.

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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

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?

Measurement of gas exchange under different inhaled oxygen concentrations (time frame: At the time of presentation (on day 1)). The study lists 10 primary outcomes in all. 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 NCT05374577, which also lists 13 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 4 Sep 2025.

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