Clinical Trials

Pulmonary Artery Pressure in COVID-19 Survivors

Study Purpose

Post COVID-19 pulmonary hypertension can develop as a result of lung parenchymal damage and altered pulmonary circulation induced by COVID-19 infection. It has been proposed that this type of PH should be considered a combination between PH of group 3 (due to interstitial fibrosis and alveolar inflammation) and 4 (induced by thrombotic/thromboembolic processes, endothelial injury, or, at least, hypoxic vasoconstriction). Right heart catheterization (RHC) is the gold standard for assessing pulmonary hemodynamics and is mandatory for confirming the diagnosis of pulmonary hypertension (PH), assessing the severity of hemodynamic impairment, and performing vasoreactivity testing in selected patients

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- COVID-19 survivors from a moderate/severe COVID-19 pulmonary infection according to WHO COVID-19 clinical severity classification , ≥ 18 years, with residual symptoms and signs suggestive of pulmonary hypertension and not explained by other condition.

Exclusion Criteria:

- Previous diseases that could explain the existence of PH e.g. cardiovascular, pulmonary diseases or history of pulmonary thromboembolism.

- Hemodynamic instability.

- Absolute contraindications to RHC placement include: - Infection at the insertion site.

- The presence of a right ventricular assist device.

- Insertion during cardiopulmonary bypass.

- Lack of consent.

- Relative contraindications to RHC placement include: - Coagulopathy (INR >1.5), thrombocytopenia (platelet count <50,000/microL).

- Electrolyte disturbances.

- Severe acid-base disturbances.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05993338
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mansoura University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mohamed Abd Elmoniem
Principal Investigator Affiliation	assistant lecturer chest medicine Mansoura university
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension Secondary

Additional Details

Coronavirus disease 2019 (COVID-19), the highly contagious viral illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has had a catastrophic effect on the world's demographics resulting in more than 3.8 million deaths worldwide, emerging as the most consequential global health crisis since the era of the influenza pandemic of 1918. COVID-19 survivors may experience persistent symptoms affecting different organ systems after the acute phase of infection. Early reports suggest residual effects of SARS-CoV-2 infection, involving respiratory, cardiovascular, musculoskeletal, integumentary, gastrointestinal, endocrine, and neurological systems. Post-acute COVID-19 could be defined as persistent symptoms and/or delayed or long-term complications of SARS-CoV-2 infection beyond 4 weeks from the onset of symptoms. It is further divided into two categories:

(1) subacute or ongoing symptomatic COVID-19, which includes symptoms and abnormalities present from 4-12 weeks beyond acute COVID-19; and (2) chronic or post-COVID- 19 syndrome, which includes symptoms and abnormalities persisting or present beyond 12 weeks of the onset of acute COVID-19 and not attributable to alternative diagnoses.

Pulmonary hypertension (PH) is a clinical disorder involving multiple pathophysiological processes that ultimately affect the vasculature within the lungs. According to the 6th World Symposium on Pulmonary Hypertension, pulmonary hypertension (PH) is defined by mean pulmonary arterial pressure (mPAP) >20 mmHg. "Pre-capillary PH" is considered if additionally pulmonary arterial wedge pressure (PAWP) is ≤15 mmHg and pulmonary vascular resistance (PVR) is ≥3 Wood units (WU). "Post-capillary PH" is defined as mPAP >20 mmHg with PAWP >15 mmHg. In the case of PVR <3 WU, we talk about "isolated post-capillary PH", while in the case of PVR ≥3 WU the criteria for "combined pre- and post-capillary PH" are fulfilled. Post COVID-19 pulmonary hypertension can develop as a result of lung parenchymal damage and altered pulmonary circulation induced by COVID-19 infection. It has been proposed that this type of PH should be considered a combination between PH of group 3 (due to interstitial fibrosis and alveolar inflammation) and 4 (induced by thrombotic/thromboembolic processes, endothelial injury, or, at least, hypoxic vasoconstriction). Right heart catheterization (RHC) is the gold standard for assessing pulmonary hemodynamics and is mandatory for confirming the diagnosis of pulmonary hypertension (PH), assessing the severity of hemodynamic impairment, and performing vasoreactivity testing in selected patients. Hypothesis and assumptions: We hypothesize that pulmonary hypertension explain some of residual symptoms in COVID-19 survivors. Aim of work: The aim of this study is to assess pulmonary hemodynamics in COVID-19 survivors.

Arms & Interventions

Arms

Experimental: assess pulmonary hemodynamics in COVID-19 survivors

COVID-19 survivors from a moderate/severe COVID-19 pulmonary infection according to WHO COVID-19 clinical severity classification, ≥ 18 years, with residual symptoms and signs suggestive of pulmonary hypertension and not explained by other condition

Interventions

Diagnostic Test: - right heart catheterization (RHC).

Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC).

Contact a Trial Team

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International Sites

faculty of medicine Mansoura university, Mansoura, Egypt

Status

Address

faculty of medicine Mansoura university

Mansoura, ,