Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550648
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Evaluation of the Role of Epstein-Bar Virus in Patients With Pulmonary Arterial Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Role of Epstein-Bar Virus in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the role of Epstein-Barr virus infection in PAH Idiopathic and connective tissue disease
This by obtaining a blood sample from the PAH patients undergoing right heart cathetrization as well as obtaining the endothelial cells from the balloon tipped catheters and extracting the EBV virus to detect its presence
IgG IgM and PCR for EBV tests will be done
This by obtaining a blood sample from the PAH patients undergoing right heart cathetrization as well as obtaining the endothelial cells from the balloon tipped catheters and extracting the EBV virus to detect its presence
IgG IgM and PCR for EBV tests will be done
Detailed Description:
About Pulmonary Hypertension Pulmonary hypertension PH is a pathophysiological disorder that may involve multiple clinical conditions combined with a variety of cardiovascular and respiratory diseases It is defined by a mean pulmonary arterial pressure mPAP of more than 20 mmHg at rest Humbert Met al 2022
Pulmonary arterial hypertension PAH is a condition characterized by vascular proliferation leading to increased vascular resistance and right heart dysfunction PAH may be idiopathic Idiopathic Pulmonary Arterial Hypertension IPAH previously known as primary pulmonary hypertension PPH or associated with other conditions or exposures including connective tissue diseases HIV infection portal hypertension and anorexigenic drug ingestion Humbert Met al 2022
About Chronic active Epstein-Barr virus Chronic Active Epstein-Barr virus CAEBV disease is usually defined as a chronic illness lasting at least 6 months an increased EBV level in either the tissue or the blood and lack of evidence of a known underlying immunodeficiency It may be associated with Burkitt lymphoma and nasopharyngeal carcinoma Hodgkin lymphoma peripheral T cell lymphoma angioimmunoblastic T cell lymphoma and extranodal NKT cell lymphoma Kimura et al 2017
CAEBV is characterized by an unusual pattern of anti-EBV antibodies and may be associated with cardiovascular abnormalities Hashimoto et al 2011
Diagnosis of Epstein-Barr virus EBV infection is based on clinical symptoms and serological markers including the following immunoglobulin G IgG and IgM antibodies to the viral capsid antigen VCA heterophile antibodies and IgG antibodies to the EBV early antigen-diffuse EA-D and nuclear antigen EBNA-1Klutts JS Et al 2009
Elevated levels of EBV DNA in the blood are more specific for CAEBV than elevated levels of EBV antibodies Kimura H et al 2017
Role of EBV in PAH The relationships between EBV and autoimmune diseases are complex and involve several mechanisms A proposed scenario was the interrelation between genetic predisposition and EBV infection a cross-reaction between self antigens and EBV viral proteins the development of autoantibodies anti-Sm or anti-Ro antibodies in SLE anti-CCP antibodies in RA an epitope-spreading process that can lead to the development of additional non-cross-reactive autoepitopes and finally the clinical manifestations Poole BD et al2006
EBV has multiple impacts on host immunity and can adapt to its environment For instance EBV produces an IL-10-like cytokine it can modulate IL-6 release it induces the production of TNF-a by infected B cells and it can inhibit apoptosis of infected B cells by the production of a Bcl-2 homolog All these biological properties of EBV are relevant to and can contribute to the pathophysiology of autoimmune disorders Toussirot É et al2008
The pathophysiology of the development of PAH in CAEBV is unclear It may be related to lymphocytic infiltration and the resultant damage to the pulmonary vascular endothelium caused by EBV infection or may occur secondary to the vascular damage caused by inflammatory reactions induced by EBV infection Gotoh K et al 2008
Another is EBV-induced high levels of inflammatory cytokines resulting in inflammatory change Fujiwara M et al 2003
Pulmonary arterial hypertension PAH is a condition characterized by vascular proliferation leading to increased vascular resistance and right heart dysfunction PAH may be idiopathic Idiopathic Pulmonary Arterial Hypertension IPAH previously known as primary pulmonary hypertension PPH or associated with other conditions or exposures including connective tissue diseases HIV infection portal hypertension and anorexigenic drug ingestion Humbert Met al 2022
About Chronic active Epstein-Barr virus Chronic Active Epstein-Barr virus CAEBV disease is usually defined as a chronic illness lasting at least 6 months an increased EBV level in either the tissue or the blood and lack of evidence of a known underlying immunodeficiency It may be associated with Burkitt lymphoma and nasopharyngeal carcinoma Hodgkin lymphoma peripheral T cell lymphoma angioimmunoblastic T cell lymphoma and extranodal NKT cell lymphoma Kimura et al 2017
CAEBV is characterized by an unusual pattern of anti-EBV antibodies and may be associated with cardiovascular abnormalities Hashimoto et al 2011
Diagnosis of Epstein-Barr virus EBV infection is based on clinical symptoms and serological markers including the following immunoglobulin G IgG and IgM antibodies to the viral capsid antigen VCA heterophile antibodies and IgG antibodies to the EBV early antigen-diffuse EA-D and nuclear antigen EBNA-1Klutts JS Et al 2009
Elevated levels of EBV DNA in the blood are more specific for CAEBV than elevated levels of EBV antibodies Kimura H et al 2017
Role of EBV in PAH The relationships between EBV and autoimmune diseases are complex and involve several mechanisms A proposed scenario was the interrelation between genetic predisposition and EBV infection a cross-reaction between self antigens and EBV viral proteins the development of autoantibodies anti-Sm or anti-Ro antibodies in SLE anti-CCP antibodies in RA an epitope-spreading process that can lead to the development of additional non-cross-reactive autoepitopes and finally the clinical manifestations Poole BD et al2006
EBV has multiple impacts on host immunity and can adapt to its environment For instance EBV produces an IL-10-like cytokine it can modulate IL-6 release it induces the production of TNF-a by infected B cells and it can inhibit apoptosis of infected B cells by the production of a Bcl-2 homolog All these biological properties of EBV are relevant to and can contribute to the pathophysiology of autoimmune disorders Toussirot É et al2008
The pathophysiology of the development of PAH in CAEBV is unclear It may be related to lymphocytic infiltration and the resultant damage to the pulmonary vascular endothelium caused by EBV infection or may occur secondary to the vascular damage caused by inflammatory reactions induced by EBV infection Gotoh K et al 2008
Another is EBV-induced high levels of inflammatory cytokines resulting in inflammatory change Fujiwara M et al 2003
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None