COVID-19
Conditions
Brief 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
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.
Interventions
OTHERpulmonary 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)
OTHERpulmonary 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.
Sponsors
University of Giessen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Invasive hemodynamics - cardiac Index (CI; l/min/m2) | At the time of presentation (on day 1) | Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup) |
| Invasive hemodynamics - pulmonary vascular resistance (PVR; WU) | At the time of presentation (on day 1) | Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup) |
| Measurement of gas exchange under different inhaled oxygen concentrations | At the time of presentation (on day 1) | Non-invasive estimation of ventilation/perfusion (V/Q) mismatch |
| Spiroergometric capacity- maximal oxygen uptake (VO2max; ml/min/kg) | At the time of presentation (on day 1) | Determination of exercise capacity by cardiopulmonary exercise testing (CPET) |
| Echocardiographic right heart parameters - pulmonary arterial systolic pressure (PASP; mmHg) | At the time of presentation (on day 1) | Echocardiographic determination of right heart parameters under rest and during exercise |
| Echocardiographic right heart parameters - Tricuspid annular plane systolic excursion (TAPSE; mm) | At the time of presentation (on day 1) | Echocardiographic determination of right heart parameters under rest and during exercise |
| Echocardiographic right heart parameters - right ventricular (RV) end-ventricular volume (EDV; ml) | At the time of presentation (on day 1) | Echocardiographic determination of right heart parameters under rest and during exercise |
| Echocardiographic right heart - right volume (RV) end-systolic volume (ESV; ml) | At the time of presentation (on day 1) | Echocardiographic determination of right heart parameters under rest and during exercise |
| Echocardiographic right heart - right ventricular longitudinal global strain (%) | At the time of presentation (on day 1) | Echocardiographic determination of right heart parameters under rest and during exercise |
| Dyspnoea Index | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left heart parameters - (E/e' ratio) | At the time of presentation (on day 1) | Determination of left heart parameters during rest and exercise |
| Static and dynamic lung function parameters - diffusion coefficient (DLCO/VA; %) | At the time of presentation (on day 1) | Determination of lung function by body plethysmography at rest |
| Left heart parameters - left ventricular ejection fraction (%) | At the time of presentation (on day 1) | Determination of left heart parameters during rest and exercise |
| Pulmonary vascular function | At the time of presentation (on day 1) | Increase of echocardiographically estimated systolic pulmonary arterial pressure during inhalation of hypoxic gas |
| Airway Impedance | At the time of presentation (on day 1) | Determination of airway impedance by oscillometry |
| Peripheral blood mononuclear cells | At the time of presentation (on day 1) | Determination of characteristics of peripheral immune cells by fluorescence activated cell sorter (FACS) and functional assays |
| Shunt measurement | At the time of presentation (on day 1) | Shunt measurement by contrast-enhanced echocardiography (optional) |
| Ventilation/Perfusion mismatch | 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) |
| Static and dynamic lung function parameters - vital capacity (VC; L) | At the time of presentation (on day 1) | Determination of lung function by body plethysmography at rest |
| Static and dynamic lung function parameters - forced expiratory volume in 1 s (FEV1; L) | At the time of presentation (on day 1) | Determination of lung function by body plethysmography at rest |
| Static and dynamic lung function parameters - diffusion capacity (DLCO; %) | At the time of presentation (on day 1) | Determination of lung function by body plethysmography at rest |
Countries
Germany
Outcome results
None listed