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

N/AActive Not RecruitingNCT05374577

University of Giessen200 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

COVID-19

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Natascha Sommer

Giessen, Germany

Outcomes

Primary Outcomes

Measurement of gas exchange under different inhaled oxygen concentrations

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

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

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

Determination of exercise capacity by cardiopulmonary exercise testing (CPET)

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

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

Echocardiographic determination of right heart parameters under rest and during exercise

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

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

Echocardiographic determination of right heart parameters under rest and during exercise

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

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

Echocardiographic determination of right heart parameters under rest and during exercise

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

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

Echocardiographic determination of right heart parameters under rest and during exercise

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

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

Echocardiographic determination of right heart parameters under rest and during exercise

Data from ClinicalTrials.gov

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Secondary Outcomes

Left heart parameters - (E/e' ratio)

Determination of left heart parameters during rest and exercise

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

Left heart parameters - left ventricular ejection fraction (%)

Determination of left heart parameters during rest and exercise

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

Pulmonary vascular function

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

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

Airway Impedance

Determination of airway impedance by oscillometry

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

Peripheral blood mononuclear cells

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

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

Shunt measurement

Shunt measurement by contrast-enhanced echocardiography (optional)

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

Ventilation/Perfusion mismatch

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

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

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

Determination of lung function by body plethysmography at rest

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

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

Determination of lung function by body plethysmography at rest

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

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

Determination of lung function by body plethysmography at rest

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

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

Determination of lung function by body plethysmography at rest

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