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Pulmonary Artery Pressure in COVID-19 Survivors

Primary Purpose

Pulmonary Hypertension Secondary

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
right heart catheterization (RHC).
Sponsored by
Mansoura University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension Secondary focused on measuring pulmonary artery pressure, COVID-19 survivors, right heart catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • faculty of medicine Mansoura university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

assess pulmonary hemodynamics in COVID-19 survivors

Arm Description

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

Outcomes

Primary Outcome Measures

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The pulmonary artery blood sample is withdrawn using the distal yellow port, and mixed venous oxygen saturation (SvO2) is obtained.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]

Secondary Outcome Measures

Full Information

First Posted
August 13, 2023
Last Updated
August 25, 2023
Sponsor
Mansoura University Hospital
Collaborators
Ahmed Abdel-Gawad Mohamed Radi, Magdy Mahmoud emara, Tamer Ali Elhadidy, Mohammed Ahmed ibrahim
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1. Study Identification

Unique Protocol Identification Number
NCT05993338
Brief Title
Pulmonary Artery Pressure in COVID-19 Survivors
Official Title
Assessment of Pulmonary Artery Pressure in COVID-19 Survivors Using Right Heart Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Hospital
Collaborators
Ahmed Abdel-Gawad Mohamed Radi, Magdy Mahmoud emara, Tamer Ali Elhadidy, Mohammed Ahmed ibrahim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension Secondary
Keywords
pulmonary artery pressure, COVID-19 survivors, right heart catheterization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
assess pulmonary hemodynamics in COVID-19 survivors
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
assess pulmonary hemodynamics in COVID-19 survivors
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
right heart catheterization (RHC).
Intervention Description
Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC).
Primary Outcome Measure Information:
Title
Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC)
Description
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]
Time Frame
1.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abd Elmoniem
Organizational Affiliation
assistant lecturer chest medicine Mansoura university
Official's Role
Study Director
Facility Information:
Facility Name
faculty of medicine Mansoura university
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulmonary Artery Pressure in COVID-19 Survivors

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