COVID-19 Clinical Trial
— PulmVasCOfficial title:
Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After COVID-19 (PulmVasC)- A Multicenter, Prospective Cohort/Observational Study
NCT number | NCT05374577 |
Other study ID # | KKS-300 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2022 |
Est. completion date | June 2025 |
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
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Germany | Natascha Sommer | Giessen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen |
Germany,
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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | Echocardiographic right heart - right ventricular longitudinal global strain (%) | Echocardiographic determination of right heart parameters under rest and during exercise | At the time of presentation (on day 1) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Secondary | Left heart parameters - (E/e' ratio) | Determination of left heart parameters during rest and exercise | At the time of presentation (on day 1) | |
Secondary | Left heart parameters - left ventricular ejection fraction (%) | Determination of left heart parameters during rest and exercise | At the time of presentation (on day 1) | |
Secondary | Pulmonary vascular function | Increase of echocardiographically estimated systolic pulmonary arterial pressure during inhalation of hypoxic gas | At the time of presentation (on day 1) | |
Secondary | Airway Impedance | Determination of airway impedance by oscillometry | At the time of presentation (on day 1) | |
Secondary | 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) | |
Secondary | Shunt measurement | Shunt measurement by contrast-enhanced echocardiography (optional) | At the time of presentation (on day 1) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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