xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993338</url>
    </required_header>
    <id_info>
      <org_study_id>MD.22.04.638</org_study_id>
      <nct_id>NCT05993338</nct_id>
    </id_info>
    <brief_title>Pulmonary Artery Pressure in COVID-19 Survivors</brief_title>
    <official_title>Assessment of Pulmonary Artery Pressure in COVID-19 Survivors Using Right Heart Catheterization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ahmed Abdel-Gawad Mohamed Radi</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Magdy Mahmoud emara</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tamer Ali Elhadidy</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mohammed Ahmed ibrahim</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mansoura University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Post COVID-19 pulmonary hypertension can develop as a result of lung parenchymal damage and&#xD;
        altered pulmonary circulation induced by COVID-19 infection. It has been proposed that this&#xD;
        type of PH should be considered a combination between PH of group 3 (due to interstitial&#xD;
        fibrosis and alveolar inflammation) and 4 (induced by thrombotic/thromboembolic processes,&#xD;
        endothelial injury, or, at least, hypoxic vasoconstriction). Right heart catheterization&#xD;
        (RHC) is the gold standard for assessing pulmonary hemodynamics and is mandatory for&#xD;
        confirming the diagnosis of pulmonary hypertension (PH), assessing the severity of&#xD;
        hemodynamic impairment, and performing vasoreactivity testing in selected patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coronavirus disease 2019 (COVID-19), the highly contagious viral illness caused by severe&#xD;
        acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has had a catastrophic effect on the&#xD;
        world's demographics resulting in more than 3.8 million deaths worldwide, emerging as the&#xD;
        most consequential global health crisis since the era of the influenza pandemic of 1918.&#xD;
        COVID-19 survivors may experience persistent symptoms affecting different organ systems after&#xD;
        the acute phase of infection. Early reports suggest residual effects of SARS-CoV-2 infection,&#xD;
        involving respiratory, cardiovascular, musculoskeletal, integumentary, gastrointestinal,&#xD;
        endocrine, and neurological systems. Post-acute COVID-19 could be defined as persistent&#xD;
        symptoms and/or delayed or long-term complications of SARS-CoV-2 infection beyond 4 weeks&#xD;
        from the onset of symptoms. It is further divided into two categories: (1) subacute or&#xD;
        ongoing symptomatic COVID-19, which includes symptoms and abnormalities present from 4-12&#xD;
        weeks beyond acute COVID-19; and (2) chronic or post-COVID- 19 syndrome, which includes&#xD;
        symptoms and abnormalities persisting or present beyond 12 weeks of the onset of acute&#xD;
        COVID-19 and not attributable to alternative diagnoses. Pulmonary hypertension (PH) is a&#xD;
        clinical disorder involving multiple pathophysiological processes that ultimately affect the&#xD;
        vasculature within the lungs.&#xD;
  &#xD;
        According to the 6th World Symposium on Pulmonary Hypertension, pulmonary hypertension (PH)&#xD;
        is defined by mean pulmonary arterial pressure (mPAP) &gt;20 mmHg. &quot;Pre-capillary PH&quot; is&#xD;
        considered if additionally pulmonary arterial wedge pressure (PAWP) is ≤15 mmHg and pulmonary&#xD;
        vascular resistance (PVR) is ≥3 Wood units (WU). &quot;Post-capillary PH&quot; is defined as mPAP &gt;20&#xD;
        mmHg with PAWP &gt;15 mmHg. In the case of PVR &lt;3 WU, we talk about &quot;isolated post-capillary&#xD;
        PH&quot;, while in the case of PVR ≥3 WU the criteria for &quot;combined pre- and post-capillary PH&quot;&#xD;
        are fulfilled. Post COVID-19 pulmonary hypertension can develop as a result of lung&#xD;
        parenchymal damage and altered pulmonary circulation induced by COVID-19 infection. It has&#xD;
        been proposed that this type of PH should be considered a combination between PH of group 3&#xD;
        (due to interstitial fibrosis and alveolar inflammation) and 4 (induced by&#xD;
        thrombotic/thromboembolic processes, endothelial injury, or, at least, hypoxic&#xD;
        vasoconstriction). Right heart catheterization (RHC) is the gold standard for assessing&#xD;
        pulmonary hemodynamics and is mandatory for confirming the diagnosis of pulmonary&#xD;
        hypertension (PH), assessing the severity of hemodynamic impairment, and performing&#xD;
        vasoreactivity testing in selected patients.&#xD;
  &#xD;
        Hypothesis and assumptions:&#xD;
  &#xD;
        We hypothesize that pulmonary hypertension explain some of residual symptoms in COVID-19&#xD;
        survivors.&#xD;
  &#xD;
        Aim of work:&#xD;
  &#xD;
        The aim of this study is to assess pulmonary hemodynamics in COVID-19 survivors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Actual">April 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>assess pulmonary hemodynamics in COVID-19 survivors</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC)</measure>
      <time_frame>1.5 year</time_frame>
      <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]</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Pulmonary Hypertension Secondary</condition>
    <arm_group>
      <arm_group_label>assess pulmonary hemodynamics in COVID-19 survivors</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>right heart catheterization (RHC).</intervention_name>
      <description>Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC).</description>
      <arm_group_label>assess pulmonary hemodynamics in COVID-19 survivors</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  COVID-19 survivors from a moderate/severe COVID-19 pulmonary infection according to&#xD;
               WHO COVID-19 clinical severity classification , ≥ 18 years, with residual symptoms and&#xD;
               signs suggestive of pulmonary hypertension and not explained by other condition.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous diseases that could explain the existence of PH e.g. cardiovascular,&#xD;
               pulmonary diseases or history of pulmonary thromboembolism.&#xD;
  &#xD;
            -  Hemodynamic instability.&#xD;
  &#xD;
            -  Absolute contraindications to RHC placement include:&#xD;
  &#xD;
            -  Infection at the insertion site.&#xD;
  &#xD;
            -  The presence of a right ventricular assist device.&#xD;
  &#xD;
            -  Insertion during cardiopulmonary bypass.&#xD;
  &#xD;
            -  Lack of consent.&#xD;
  &#xD;
            -  Relative contraindications to RHC placement include:&#xD;
  &#xD;
            -  Coagulopathy (INR &gt;1.5), thrombocytopenia (platelet count &lt;50,000/microL).&#xD;
  &#xD;
            -  Electrolyte disturbances.&#xD;
  &#xD;
            -  Severe acid-base disturbances.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed Abd Elmoniem</last_name>
      <role>Study Director</role>
      <affiliation>assistant lecturer chest medicine Mansoura university</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>faculty of medicine Mansoura university</name>
        <address>
          <city>Mansoura</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University Hospital</investigator_affiliation>
      <investigator_full_name>Mohamed Abd Elmoniem Mohamed</investigator_full_name>
      <investigator_title>Assistant lecturer chest medicine-Mansoura univerisity-Mansoura-Egypt</investigator_title>
    </responsible_party>
    <keyword>pulmonary artery pressure</keyword>
    <keyword>COVID-19 survivors</keyword>
    <keyword>right heart catheterization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Hypertension, Pulmonary</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993338
  org study id: MD.22.04.638
  nct id: NCT05993338
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: assess pulmonary hemodynamics in COVID-19 survivors
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC)
  time frame: 1.5 year
  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]
  arm group label: assess pulmonary hemodynamics in COVID-19 survivors
  arm group type: Experimental
  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: right heart catheterization (RHC).
  description: Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC).
  arm group label: assess pulmonary hemodynamics in COVID-19 survivors
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mohamed Abd Elmoniem
  role: Study Director
  affiliation: assistant lecturer chest medicine Mansoura university
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University Hospital
  investigator full name: Mohamed Abd Elmoniem Mohamed
  investigator title: Assistant lecturer chest medicine-Mansoura univerisity-Mansoura-Egypt
  mesh term: COVID-19
  mesh term: Hypertension, Pulmonary
  sharing ipd: No