Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH (EXPERT-BPA)
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Invasive exercise testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Thromboembolic Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
-Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.
Exclusion Criteria:
-Patients unable to perform ergometer exercise
Sites / Locations
- Department of cardiology, Aarhus University HospitalRecruiting
- Nagoya University Hospital
- European Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
Exercise is added to resting right heart catheterization
Outcomes
Primary Outcome Measures
Slope of mPA/CO after BPA
Change from Baseline in Slope of mean pulmonary artery pressure/cardiac output after BPA at 6 months
Secondary Outcome Measures
Change in resting PVR after BPA
Change from Baseline in pulmonary vascular resistance (PVR) after BPA at 6 months
Change in 6 MWT after BPA
Change from Baseline in 6 minute walk test (MWT) after BPA at 6 months
Change in NT-proBNP after BPA
Change from Baseline in NT-proBNP after BPA at 6 months
Full Information
NCT ID
NCT04052243
First Posted
July 11, 2019
Last Updated
July 18, 2022
Sponsor
Aarhus University Hospital
Collaborators
Nagoya University, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
1. Study Identification
Unique Protocol Identification Number
NCT04052243
Brief Title
Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH
Acronym
EXPERT-BPA
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
Nagoya University, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
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6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Exercise is added to the resting right heart catheterization.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Arm Description
Exercise is added to resting right heart catheterization
Intervention Type
Diagnostic Test
Intervention Name(s)
Invasive exercise testing
Intervention Description
Invasive hemodynamic exercise testing
Primary Outcome Measure Information:
Title
Slope of mPA/CO after BPA
Description
Change from Baseline in Slope of mean pulmonary artery pressure/cardiac output after BPA at 6 months
Time Frame
6 months after last BPA session
Secondary Outcome Measure Information:
Title
Change in resting PVR after BPA
Description
Change from Baseline in pulmonary vascular resistance (PVR) after BPA at 6 months
Time Frame
6 months after last BPA session
Title
Change in 6 MWT after BPA
Description
Change from Baseline in 6 minute walk test (MWT) after BPA at 6 months
Time Frame
6 months after last BPA session
Title
Change in NT-proBNP after BPA
Description
Change from Baseline in NT-proBNP after BPA at 6 months
Time Frame
6 months after last BPA session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.
Exclusion Criteria:
-Patients unable to perform ergometer exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mads J Andersen, MD, PhD
Phone
+45784500000
Email
madsae@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Erik Nielsen-Kudsk, MD, Dm.Sci.
Facility Information:
Facility Name
Department of cardiology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mads J Andersen, MD, PhD
Phone
+4578450000
Email
madsae@rm.dk
First Name & Middle Initial & Last Name & Degree
Jens Erik Nielsen-Kudsk, MD, Dm.Sci
Facility Name
Nagoya University Hospital
City
Nagoya
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiro Adachi, PhD
First Name & Middle Initial & Last Name & Degree
Shiro Adachi
Facility Name
European Health Center
City
Otwock
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szymon Darocha, PhD
First Name & Middle Initial & Last Name & Degree
Szymon Darocha
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH
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