Clinical trial NCT05374577: Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After Coronavirus Disease (COVID-19)
Official title: Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After COVID-19 (PulmVasC)- A Multicenter, Prospective Cohort/Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measurement of gas exchange under different inhaled oxygen concentrations
timeFrame: At the time of presentation (on day 1)
measure: Spiroergometric capacity- maximal oxygen uptake (VO2max; ml/min/kg)
timeFrame: At the time of presentation (on day 1)
measure: Echocardiographic right heart parameters - pulmonary arterial systolic pressure (PASP; mmHg)
timeFrame: At the time of presentation (on day 1)
measure: Echocardiographic right heart parameters - Tricuspid annular plane systolic excursion (TAPSE; mm)
timeFrame: At the time of presentation (on day 1)
measure: Echocardiographic right heart parameters - right ventricular (RV) end-ventricular volume (EDV; ml)
timeFrame: At the time of presentation (on day 1)
measure: Echocardiographic right heart - right volume (RV) end-systolic volume (ESV; ml)
timeFrame: At the time of presentation (on day 1)
measure: Echocardiographic right heart - right ventricular longitudinal global strain (%)
timeFrame: At the time of presentation (on day 1)
measure: Dyspnoea Index
timeFrame: At the time of presentation (on day 1)
measure: Invasive hemodynamics - pulmonary vascular resistance (PVR; WU)
timeFrame: At the time of presentation (on day 1)
measure: Invasive hemodynamics - cardiac Index (CI; l/min/m2)
timeFrame: At the time of presentation (on day 1)
Secondary outcomes:
measure: Left heart parameters - (E/e' ratio)
timeFrame: At the time of presentation (on day 1)
measure: Left heart parameters - left ventricular ejection fraction (%)
timeFrame: At the time of presentation (on day 1)
measure: Pulmonary vascular function
timeFrame: At the time of presentation (on day 1)
measure: Airway Impedance
timeFrame: At the time of presentation (on day 1)
measure: Peripheral blood mononuclear cells
timeFrame: At the time of presentation (on day 1)
measure: Shunt measurement
timeFrame: At the time of presentation (on day 1)
measure: Ventilation/Perfusion mismatch
timeFrame: At the time of presentation (on day 1)
measure: Static and dynamic lung function parameters - vital capacity (VC; L)
timeFrame: At the time of presentation (on day 1)
measure: Static and dynamic lung function parameters - forced expiratory volume in 1 s (FEV1; L)
timeFrame: At the time of presentation (on day 1)
measure: Static and dynamic lung function parameters - diffusion capacity (DLCO; %)
timeFrame: At the time of presentation (on day 1)
measure: Static and dynamic lung function parameters - diffusion coefficient (DLCO/VA; %)
timeFrame: At the time of presentation (on day 1)
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Natascha Sommer
Study officials:
affiliation: Cardiopulmonary Institute (CPI), University of Giessen and Marburg Lung Center (UGMLC)
name: Natascha Sommer, PD
role: PRINCIPAL_INVESTIGATOR
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