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

September 3, 2025 updated by: University of Giessen

Pulmonary Vascular Dysfunction as a Cause of Persistent Exertional Dyspnea After COVID-19 (PulmVasC)- A Multicenter, Prospective Cohort/Observational Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Giessen, Germany
        • Natascha Sommer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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 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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of gas exchange under different inhaled oxygen concentrations
Time Frame: At the time of presentation (on day 1)
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)
Time Frame: At the time of presentation (on day 1)
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)
Time Frame: At the time of presentation (on day 1)
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)
Time Frame: At the time of presentation (on day 1)
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)
Time Frame: At the time of presentation (on day 1)
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)
Time Frame: At the time of presentation (on day 1)
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 (%)
Time Frame: At the time of presentation (on day 1)
Echocardiographic determination of right heart parameters under rest and during exercise
At the time of presentation (on day 1)
Dyspnoea Index
Time Frame: 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
At the time of presentation (on day 1)
Invasive hemodynamics - pulmonary vascular resistance (PVR; WU)
Time Frame: At the time of presentation (on day 1)
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)
Time Frame: At the time of presentation (on day 1)
Invasive measurement of pulmonary hemodynamics by right heart catheterization (RHC subgroup)
At the time of presentation (on day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left heart parameters - (E/e' ratio)
Time Frame: At the time of presentation (on day 1)
Determination of left heart parameters during rest and exercise
At the time of presentation (on day 1)
Left heart parameters - left ventricular ejection fraction (%)
Time Frame: At the time of presentation (on day 1)
Determination of left heart parameters during rest and exercise
At the time of presentation (on day 1)
Pulmonary vascular function
Time Frame: At the time of presentation (on day 1)
Increase of echocardiographically estimated systolic pulmonary arterial pressure during inhalation of hypoxic gas
At the time of presentation (on day 1)
Airway Impedance
Time Frame: At the time of presentation (on day 1)
Determination of airway impedance by oscillometry
At the time of presentation (on day 1)
Peripheral blood mononuclear cells
Time Frame: At the time of presentation (on day 1)
Determination of characteristics of peripheral immune cells by fluorescence activated cell sorter (FACS) and functional assays
At the time of presentation (on day 1)
Shunt measurement
Time Frame: At the time of presentation (on day 1)
Shunt measurement by contrast-enhanced echocardiography (optional)
At the time of presentation (on day 1)
Ventilation/Perfusion mismatch
Time Frame: 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)
At the time of presentation (on day 1)
Static and dynamic lung function parameters - vital capacity (VC; L)
Time Frame: At the time of presentation (on day 1)
Determination of lung function by body plethysmography at rest
At the time of presentation (on day 1)
Static and dynamic lung function parameters - forced expiratory volume in 1 s (FEV1; L)
Time Frame: At the time of presentation (on day 1)
Determination of lung function by body plethysmography at rest
At the time of presentation (on day 1)
Static and dynamic lung function parameters - diffusion capacity (DLCO; %)
Time Frame: At the time of presentation (on day 1)
Determination of lung function by body plethysmography at rest
At the time of presentation (on day 1)
Static and dynamic lung function parameters - diffusion coefficient (DLCO/VA; %)
Time Frame: At the time of presentation (on day 1)
Determination of lung function by body plethysmography at rest
At the time of presentation (on day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Giessen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natascha Sommer, PD, Cardiopulmonary Institute (CPI), University of Giessen and Marburg Lung Center (UGMLC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KKS-300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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