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NCT Number: NCT05374577

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Natascha Sommer

Giessen, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

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)

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.

Primary outcomes

  1. Measurement of gas exchange under different inhaled oxygen concentrations

    Time frame: At the time of presentation (on day 1)

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

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

    Time frame: At the time of presentation (on day 1)

    Determination of exercise capacity by cardiopulmonary exercise testing (CPET)

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

    Time frame: At the time of presentation (on day 1)

    Echocardiographic determination of right heart parameters under rest and during exercise

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

    Time frame: At the time of presentation (on day 1)

    Echocardiographic determination of right heart parameters under rest and during exercise

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

    Time frame: At the time of presentation (on day 1)

    Echocardiographic determination of right heart parameters under rest and during exercise

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

    Time frame: At the time of presentation (on day 1)

    Echocardiographic determination of right heart parameters under rest and during exercise

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

    Time frame: At the time of presentation (on day 1)

    Echocardiographic determination of right heart parameters under rest and during exercise

  8. Dyspnoea Index

    Time frame: At the time of presentation (on day 1)

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

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

    Time frame: At the time of presentation (on day 1)

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

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

    Time frame: At the time of presentation (on day 1)

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

Secondary outcomes

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

    Time frame: At the time of presentation (on day 1)

    Determination of left heart parameters during rest and exercise

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

    Time frame: At the time of presentation (on day 1)

    Determination of left heart parameters during rest and exercise

  3. Pulmonary vascular function

    Time frame: At the time of presentation (on day 1)

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

  4. Airway Impedance

    Time frame: At the time of presentation (on day 1)

    Determination of airway impedance by oscillometry

  5. Peripheral blood mononuclear cells

    Time frame: At the time of presentation (on day 1)

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

  6. Shunt measurement

    Time frame: At the time of presentation (on day 1)

    Shunt measurement by contrast-enhanced echocardiography (optional)

  7. Ventilation/Perfusion mismatch

    Time frame: At the time of presentation (on day 1)

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

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

    Time frame: At the time of presentation (on day 1)

    Determination of lung function by body plethysmography at rest

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

    Time frame: At the time of presentation (on day 1)

    Determination of lung function by body plethysmography at rest

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

    Time frame: At the time of presentation (on day 1)

    Determination of lung function by body plethysmography at rest

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

    Time frame: At the time of presentation (on day 1)

    Determination of lung function by body plethysmography at rest

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Acronym: PulmVasC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 16, 2022
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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