Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH (EXPERT-BPA)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: Invasive exercise testing

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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• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mads J Andersen, MD, PhD; Phone Number: +45784500000; Email: madsae@rm.dk
• Study Contact Backup: Name: Jens Erik Nielsen-Kudsk, MD, Dm.Sci.

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Department of Cardiology, Aarhus University Hospital
    • Contact: Mads J Andersen, MD, PhD; Phone Number: +4578450000; Email: madsae@rm.dk
    • Contact: Jens Erik Nielsen-Kudsk, MD, Dm.Sci
• Japan
  • Nagoya, Japan
    • Not yet recruiting
    • Nagoya University Hospital
    • Contact: Shiro Adachi, PhD
    • Principal Investigator: Shiro Adachi
• Poland
  • Otwock, Poland
    • Recruiting
    • European Health Center
    • Contact: Szymon Darocha, PhD
    • Principal Investigator: Szymon Darocha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Patients unable to perform ergometer exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All patients; Exercise is added to resting right heart catheterization	Diagnostic test: Invasive exercise testing; Invasive hemodynamic exercise testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in NT-proBNP after BPA	Change from Baseline in NT-proBNP after BPA at 6 months	6 months after last BPA session

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Nagoya University; Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: EXPERT-BPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No