Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06051396
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-09-18
Brief Title:
Phenotyping of the Out-of-proportion Pulmonary Hypertension
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Phenotyping of the Out-of-proportion Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary hypertension PH is a pathophysiological disorder that may involve multiple clinical conditions and may be associated with a variety of cardiovascular and respiratory diseases The complexity of managing PH requires a multidisciplinary approach with active involvement of patients with PH in partnership with clinicians1 All age groups are affected Present estimates suggest a PH prevalence of 1 of the global population Due to the presence of cardiac and pulmonary causes of PH prevalence is higher in individuals aged 65 years Globally LHD is the leading cause of PH Lung disease especially chronic obstructive pulmonary disease COPD is the second most common cause In the UK the observed PH prevalence has doubled in the last 10 years and is currently 125 casesmillion inhabitants 2 Pulmonary hypertension is defined by a mean pulmonary arterial pressure mPAP more than 20 mmHg at rest according to the 2022 ESCERS Guidelines for the diagnosis and treatment of pulmonary hypertension It is essential to include PVR and pulmonary arterial wedge pressure PAWP in the definition of pre-capillary PH in order to discriminate elevated PAP due to pulmonary vascular disease PVD from that due to left heart disease LHD elevated pulmonary blood flow or increased intrathoracic pressure3 Clinical classification of pulmonary hypertension includes GROUP 1 Pulmonary arterial hypertension PAH GROUP 2 PH associated with left heart disease GROUP 3 PH associated with lung diseases andor hypoxia GROUP 4 PH associated with pulmonary artery obstructions and GROUP 5 PH with unclear andor multifactorial mechanisms 3 Pulmonary hypertension is frequently observed in patients with COPD andor emphysema diffuse parenchymal lung diseases and hypoventilation syndromes Pulmonary hypertension is uncommon in obstructive sleep apnoea unless other conditions coexist such as COPD or daytime hypoventilation
In patients with lung disease PH is categorized as non-severe or severe Whereas non-severe PH is common in advanced COPD and ILD defined by spirometric criteria severe PH is uncommon occurring in 1-5 of cases of COPD and 10 of patients with advanced ILD with limited data in obesity hypoventilation syndrome4 Pulmonary hypertension presenting in patients with lung disease may be due to a number of causes including undiagnosed CTEPH or PAH A number of distinct phenotypes of PH in patients with lung disease including a pulmonary vascular phenotype have been proposed The pulmonary vascular phenotype is characterized by better preserved spirometry low DLCO hypoxaemia a range of parenchymal involvement on lung imaging and a circulatory limitation to exercise5 Cardiac comorbidities are also common in patients with lung disease and may contribute to increased risk for hospitalization longer length of stay pulmonary hypertension and CVD-related mortality6 A vast category of patients suffering from parenchymal lung diseases often accompanied by minor pulmonary impairment on pulmonary function test andor CT scan with an unexplained severe degree of PH was brought to the attention of physicians In these patients the development of moderate to severe PH which is disproportionate to the degree of parenchymal lung disease and hypoxia has been termed out-of-proportion PH and an arbitrary value of 35 mm Hg mean pulmonary artery pressure has been selected to identify this category of patients7 and there is limited data about the Out-of proportion PH and it different phenotypes
In patients with lung disease PH is categorized as non-severe or severe Whereas non-severe PH is common in advanced COPD and ILD defined by spirometric criteria severe PH is uncommon occurring in 1-5 of cases of COPD and 10 of patients with advanced ILD with limited data in obesity hypoventilation syndrome4 Pulmonary hypertension presenting in patients with lung disease may be due to a number of causes including undiagnosed CTEPH or PAH A number of distinct phenotypes of PH in patients with lung disease including a pulmonary vascular phenotype have been proposed The pulmonary vascular phenotype is characterized by better preserved spirometry low DLCO hypoxaemia a range of parenchymal involvement on lung imaging and a circulatory limitation to exercise5 Cardiac comorbidities are also common in patients with lung disease and may contribute to increased risk for hospitalization longer length of stay pulmonary hypertension and CVD-related mortality6 A vast category of patients suffering from parenchymal lung diseases often accompanied by minor pulmonary impairment on pulmonary function test andor CT scan with an unexplained severe degree of PH was brought to the attention of physicians In these patients the development of moderate to severe PH which is disproportionate to the degree of parenchymal lung disease and hypoxia has been termed out-of-proportion PH and an arbitrary value of 35 mm Hg mean pulmonary artery pressure has been selected to identify this category of patients7 and there is limited data about the Out-of proportion PH and it different phenotypes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None