Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH

NCT ID: NCT04052243

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-06-30

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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Conditions

Chronic Thromboembolic Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

Exercise is added to resting right heart catheterization

Group Type: OTHER

Invasive exercise testing

Intervention Type: DIAGNOSTIC_TEST

Invasive hemodynamic exercise testing

Interventions

Invasive exercise testing

Invasive hemodynamic exercise testing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-Patients unable to perform ergometer exercise

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nagoya University

OTHER

Sponsor Role: collaborator

Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mads Jønsson Andersen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of cardiology, Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Nagoya University Hospital

Nagoya, , Japan

Site Status: NOT_YET_RECRUITING

European Health Center

Otwock, , Poland

Site Status: RECRUITING

Countries

Denmark; Japan; Poland

Central Contacts

Mads J Andersen, MD, PhD

Role: CONTACT

madsae@rm.dk

+45784500000

Jens Erik Nielsen-Kudsk, MD, Dm.Sci.

Role: CONTACT

Facility Contacts

Mads J Andersen, MD, PhD

Role: primary

madsae@rm.dk

+4578450000

Jens Erik Nielsen-Kudsk, MD, Dm.Sci

Role: backup

Shiro Adachi, PhD

Role: primary

Szymon Darocha, PhD

Role: primary

Other Identifiers

EXPERT-BPA

Identifier Type: -

Identifier Source: org_study_id