Pulmonary Artery Pressure in COVID-19 Survivors

Sponsor
Mansoura University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05993338
Collaborator
(none)
15
1
1
23
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: right heart catheterization (RHC).
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
assess pulmonary hemodynamics in COVID-19 survivorsassess pulmonary hemodynamics in COVID-19 survivors
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Pulmonary Artery Pressure in COVID-19 Survivors Using Right Heart Catheterization
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

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

Outcome Measures

Primary Outcome Measures

  1. Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC) [1.5 year]

    The pulmonary artery blood sample is withdrawn using the distal yellow port, and mixed venous oxygen saturation (SvO2) is obtained. Arterial saturation (SaO2) has to be obtained separately so as to determine the cardiac output (CO), using the Fick's method; CO, L/min = VO2/ [(SaO2 - SvO2) x Hb x 13.4)], where VO2 = 125 mL O2/min x BSA, In elderly patients (age ≥70 years), use 110 mL O2 x BSA for VO2, BSA = [(Height, cm x Weight, kg)/ 3,600]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 faculty of medicine Mansoura university Mansoura Egypt

Sponsors and Collaborators

  • Mansoura University Hospital

Investigators

  • Study Director: Mohamed Abd Elmoniem, assistant lecturer chest medicine Mansoura university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Abd Elmoniem Mohamed, Assistant lecturer chest medicine-Mansoura univerisity-Mansoura-Egypt, Mansoura University Hospital
ClinicalTrials.gov Identifier:
NCT05993338
Other Study ID Numbers:
  • MD.22.04.638
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Abd Elmoniem Mohamed, Assistant lecturer chest medicine-Mansoura univerisity-Mansoura-Egypt, Mansoura University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023