Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04052243
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2019-07-11
Brief Title:
Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
An International Multicenter Observational Study to Assess the Hemodynamic Effects of Balloon Pulmonary Angioplasty BPA at Rest and During Exercise in Chronic Thromboembolic Pulmonary Hypertension CTEPH or Chronic Thromboembolic Pulmonary Disease CTED Patients EXPERT-BPA
Status:
UNKNOWN
Status Verified Date:
2022-07
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:
EXPERT-BPA
Brief Summary:
Chronic thromboembolic pulmonary hypertension CTEPH is characterized by obstruction of the pulmonary vasculature by residual organized thrombi leading to increased pulmonary vascular resistance PVR progressive pulmonary hypertension and right heart failure
Medical therapy and balloon angioplasty BPA are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow
The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance
Medical therapy and balloon angioplasty BPA are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow
The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance
Detailed Description:
Chronic thromboembolic pulmonary hypertension CTEPH is a rare condition with a significant risk of morbidity and mortality The primary cause of CTEPH is thrombotic lesions which did not resolve after acute pulmonary embolism This causes increased pulmonary vascular resistance PVR leading to secondary remodeling of pulmonary arteries causing pulmonary hypertension and ultimately progressive right heart failure The treatment of choice is surgical pulmonary endarterectomy PEA however up to 40 cases are not treated surgically due to operability anatomic location of the lesions patient choice and comorbidities significantly increasing procedural risk A new alternative procedure balloon pulmonary angioplasty BPA has been proposed for patients with inoperable CTEPH or persistent pulmonary hypertension after pulmonary endarterectomy PEA and is currently characterized with good outcome in functional capacity hemodynamic parameters biomarkers and health-related quality of life
Exercise stress tests of the pulmonary circulation are used in workup and diagnosis of pulmonary hypertension as a hemodynamic abnormality The approach has allowed identification of patients with normal or marginally increased mPAP at rest but with symptomatic increases in mPAP at exercise related to either increased resistance or increased left atrial pressure Although this differential diagnosis is of obvious therapeutic relevance guidelines about exercise stress studies of the pulmonary circulation have not been developed until now for lack of robust evidence allowing for a consensus on clearly defined cutoff values
Neither the pathophysiology of the exercise limitation nor the underlying mechanisms of the BPA - induced improvement were studied before Therefore the aim of this study is to assess the hemodynamic effects of BPA treatment on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance Furthermore the investigators will explore possible differences in treatment effect across centers Especially explore the timing of medical therapy vs balloon angioplasty
Exercise stress tests of the pulmonary circulation are used in workup and diagnosis of pulmonary hypertension as a hemodynamic abnormality The approach has allowed identification of patients with normal or marginally increased mPAP at rest but with symptomatic increases in mPAP at exercise related to either increased resistance or increased left atrial pressure Although this differential diagnosis is of obvious therapeutic relevance guidelines about exercise stress studies of the pulmonary circulation have not been developed until now for lack of robust evidence allowing for a consensus on clearly defined cutoff values
Neither the pathophysiology of the exercise limitation nor the underlying mechanisms of the BPA - induced improvement were studied before Therefore the aim of this study is to assess the hemodynamic effects of BPA treatment on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance Furthermore the investigators will explore possible differences in treatment effect across centers Especially explore the timing of medical therapy vs balloon angioplasty
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