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

NCT05374577 | Active Not Recruiting

• 1 other identifier: KKS-300
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (11)

• Left heart parameters - (E/e' ratio)

  At the time of presentation (on day 1)

• Left heart parameters - left ventricular ejection fraction (%)

  At the time of presentation (on day 1)

• Pulmonary vascular function

  At the time of presentation (on day 1)

• Airway Impedance

  At the time of presentation (on day 1)

• Peripheral blood mononuclear cells

  At the time of presentation (on day 1)

Study Arms (2)

Patients with a suspected diagnosis of post/long-COVID-19

Patients with a suspected post-COVID-19 syndrome or a long-COVID-19 syndrome at least 3 months after severe acute respiratory syndrome coronavirus(CoV) type 2 (SARS-CoV-2) infection (symptomatic or asymptomatic)

Other: pulmonary vascular dysfunction

Patients without post/long-COVID-19 Syndrome

Patients at least 3 months after a SARS-CoV-2 infection (symptomatic or asymptomatic) without post/long-COVID-19.

Other: pulmonary vascular function

Interventions

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)

Patients with a suspected diagnosis of post/long-COVID-19

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.

Patients without post/long-COVID-19 Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

Natascha Sommer

Giessen, Germany

Location

Related Publications (13)

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  PMID: 33753937 BACKGROUND

• Gierhardt M, Pak O, Walmrath D, Seeger W, Grimminger F, Ghofrani HA, Weissmann N, Hecker M, Sommer N. Impairment of hypoxic pulmonary vasoconstriction in acute respiratory distress syndrome. Eur Respir Rev. 2021 Sep 15;30(161):210059. doi: 10.1183/16000617.0059-2021. Print 2021 Sep 30.

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  PMID: 33483331 BACKGROUND

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  PMID: 34027514 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Natascha Sommer, PD

  Cardiopulmonary Institute (CPI), University of Giessen and Marburg Lung Center (UGMLC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 16, 2022
• Study Start: April 15, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

DE (1)