Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04052243
• Other study ID #: EXPERT-BPA
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2022
• Source: Aarhus University Hospital
• Contact: Mads J Andersen, MD, PhD
• Phone: +45784500000
• Email: madsae[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.

Exclusion Criteria:

-Patients unable to perform ergometer exercise

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Diagnostic Test:
• Invasive exercise testing
Invasive hemodynamic exercise testing

Locations

Country	Name	City	State
Denmark	Department of cardiology, Aarhus University Hospital	Aarhus
Japan	Nagoya University Hospital	Nagoya
Poland	European Health Center	Otwock

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med, Nagoya University

Countries where clinical trial is conducted

Denmark,  Japan,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slope of mPA/CO after BPA	Change from Baseline in Slope of mean pulmonary artery pressure/cardiac output after BPA at 6 months	6 months after last BPA session
Secondary	Change in resting PVR after BPA	Change from Baseline in pulmonary vascular resistance (PVR) after BPA at 6 months	6 months after last BPA session
Secondary	Change in 6 MWT after BPA	Change from Baseline in 6 minute walk test (MWT) after BPA at 6 months	6 months after last BPA session
Secondary	Change in NT-proBNP after BPA	Change from Baseline in NT-proBNP after BPA at 6 months	6 months after last BPA session