Pulmonary Hypertension SecondaryNCT05993338
Pulmonary Artery Pressure in COVID-19 Survivors
A study testing right heart catheterization (RHC). in people with Pulmonary Hypertension Secondary, run by Mansoura University Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Secondary
- What is being tested?
- right heart catheterization (RHC).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Pulmonary Hypertension Secondary
- Being tested
- right heart catheterization (RHC).
- Keywords
- pulmonary artery pressure, COVID-19 survivors, right heart catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right heart catheterization (RHC).Diagnostic test
Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC).
| Study group | Role | What they receive |
|---|---|---|
| assess pulmonary hemodynamics in COVID-19 survivors | Experimental | 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 Receives: Diagnostic Test: right heart catheterization (RHC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- assess pulmonary hemodynamics in COVID-19 survivors
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
- Investigators
- Mohamed Abd Elmoniem, Study director, assistant lecturer chest medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993338
- Sponsor's protocol ID
- MD.22.04.638
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pulmonary Artery Pressure in COVID-19 Survivors Using Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT05993338
- Acronym / sponsor ID
- MD.22.04.638
- Conditions
- Pulmonary Hypertension Secondary
- Keywords
- pulmonary artery pressure, COVID-19 survivors, right heart catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- assess pulmonary hemodynamics in COVID-19 survivors
| Arm | Type | Receives |
|---|---|---|
| assess pulmonary hemodynamics in COVID-19 survivors | Experimental | Diagnostic Test: right heart catheterization (RHC).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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| right heart catheterization (RHC).Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC). | Diagnostic test | assess pulmonary hemodynamics in COVID-19 survivors |
Primary outcome
Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC)
Time frame: 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abd Elmoniem study director
assistant lecturer chest medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing right heart catheterization (RHC). in people with Pulmonary Hypertension Secondary, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pulmonary artery pressure in COVID-19 survivors using right heart catheterization (RHC) (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.