Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03205085
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2017-06-28
Brief Title:
Determinants of Right Heart Remodeling in Patients With CTEPH or PAH
Sponsor:
Centre Chirurgical Marie Lannelongue
Organization:
Centre Chirurgical Marie Lannelongue
Study Overview
Official Title:
Determinants of Postoperative Right Heart Remodeling in Patients With Chronic Thrombo-Embolic Pulmonary Hypertension After Endarterectomy or Pulmonary Arterial Hypertension After Lung Transplantation
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
PRINCEPT
Brief Summary:
Right heart failure is the main cause of morbi-mortality in patients with pulmonary hypertension PH including patients of chronic thrombo-embolic pulmonary hypertension CTEPH or pulmonary arterial hypertension PAH etiologies Endarterectomy is an effective treatment for patients with CTEPH to lower pulmonary pressure Evidence of postoperative right heart remodeling are contrasted according to the studies and determinants of right heart failure are still unclear Similarly few evidence exists on right ventricular remodeling after bilateral lung transplantation for patients with pulmonary arterial hypertension PAH Recent evidence have supported the role of inflammation and immunity in the pathophysiology of PAH While several cytokines have been shown to predict survival little is known on the implication of inflammation and immunity in postoperative Right Ventricular failure in patients with PAH
The specific translational goal of this current project is to elucidate the role of immune biomarkers in 6 months postoperative right heart adverse remodeling in patients with CTEPH or PAH We speculate that selected immune biomarkers such as CXCL9 interleukin -18 or interferon and growth factors such as HGF are correlated with mid-term postoperative right heart failure
All consecutive adults with either CTEPH referred to our center for endarterectomy or PAH referred for lung transplantation will be included aiming for 150 CTEPH and 50 PAH After inclusion patients will undergo assessment of right heart dimensions and function by cardiac magnetic resonance imaging MRI including 4-Dimensions blood flow sequences and 2D and 3D trans-thoracic echocardiography TTE as well as immune panel analysis All patients will undergo as part of routine care right heart catheterization within a week after TTE and MRI imaging On the day of surgery pulmonary pressure will be measured by right heart catheterization monitoring as part of routine care in order to estimate the drop of pressure and to adjust for the extent of endarterectomy for patients with CTEPH TTE will also be performed on the day of surgery if possible At 7 days post-endarterectomy or transplant clinical outcomes will be collected and peripheral blood will be collected Patients will be prospectively follow-up for 6 months Death need for reintervention duration of vasopressor after surgery and number duration and cause of readmission will be recorded At 6 months after surgery all survivors will undergo the same biological sampling as well as an 4D MRI and a 2D and 3D TTE Data of right heart catheterization at 6 months as part of routine care will be collected as well
The specific translational goal of this current project is to elucidate the role of immune biomarkers in 6 months postoperative right heart adverse remodeling in patients with CTEPH or PAH We speculate that selected immune biomarkers such as CXCL9 interleukin -18 or interferon and growth factors such as HGF are correlated with mid-term postoperative right heart failure
All consecutive adults with either CTEPH referred to our center for endarterectomy or PAH referred for lung transplantation will be included aiming for 150 CTEPH and 50 PAH After inclusion patients will undergo assessment of right heart dimensions and function by cardiac magnetic resonance imaging MRI including 4-Dimensions blood flow sequences and 2D and 3D trans-thoracic echocardiography TTE as well as immune panel analysis All patients will undergo as part of routine care right heart catheterization within a week after TTE and MRI imaging On the day of surgery pulmonary pressure will be measured by right heart catheterization monitoring as part of routine care in order to estimate the drop of pressure and to adjust for the extent of endarterectomy for patients with CTEPH TTE will also be performed on the day of surgery if possible At 7 days post-endarterectomy or transplant clinical outcomes will be collected and peripheral blood will be collected Patients will be prospectively follow-up for 6 months Death need for reintervention duration of vasopressor after surgery and number duration and cause of readmission will be recorded At 6 months after surgery all survivors will undergo the same biological sampling as well as an 4D MRI and a 2D and 3D TTE Data of right heart catheterization at 6 months as part of routine care will be collected as well
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