Pulmonary Artery Pressure in COVID-19 Survivors

Assessment of Pulmonary Artery Pressure in COVID-19 Survivors Using Right Heart Catheterization

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pulmonary Hypertension Secondary
• Intervention / Treatment: Diagnostic test: right heart catheterization (RHC).

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • faculty of medicine Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC)	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]	1.5 year

Collaborators and Investigators

• Sponsor: Mansoura University Hospital
• Collaborators: Ahmed Abdel-Gawad Mohamed Radi; Magdy Mahmoud emara; Tamer Ali Elhadidy; Mohammed Ahmed ibrahim
• Investigators: Study Director: Mohamed Abd Elmoniem, assistant lecturer chest medicine Mansoura university

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 13, 2023
• First Submitted That Met QC Criteria: August 13, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: right heart catheterization; pulmonary artery pressure; COVID-19 survivors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hypertension; COVID-19; Hypertension, Pulmonary
• Other Study ID Numbers: MD.22.04.638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No