Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07453017

Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization

Led by University of Sao Paulo General Hospital · Updated on 2026-03-05

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Pulmonary hypertension is a serious and progressive condition that is challenging to diagnose early due to its nonspecific symptoms. This study investigates whether electrical impedance tomography (EIT), a non-invasive and radiation-free bedside monitoring method, can provide useful information that correlates with invasive right heart catheterization (RHC) results in patients suspected of having pulmonary arterial hypertension (PAH). The goal is to assess EIT as a potential screening tool before catheterization and to aid in patient risk stratification. Adult patients referred for RHC due to suspected or confirmed PAH will undergo standard invasive hemodynamic assessment, including measurements of pulmonary artery pressure, cardiac output, and vascular resistance. Alongside, they will receive short-term EIT monitoring, with some patients also receiving a hypertonic saline injection during a respiratory pause to enhance perfusion signals. The EIT data will be analyzed offline to separate ventilation and perfusion signals and to extract pulsatility-related parameters, which will then be compared with RHC measurements. Participants will be monitored during the catheterization procedure and EIT session, with data collected to evaluate the diagnostic accuracy of EIT for detecting pulmonary hypertension. Researchers will measure the sensitivity of EIT-derived pulsatility amplitude and its correlation with invasive hemodynamic parameters. The study includes safety monitoring, with minimal risks from EIT and inherent risks from RHC. The research aims to provide insights into using EIT as a less invasive diagnostic approach for PAH, improving clinical practice and patient care.

CONDITIONS

Brief Title

Electrical Impedance Tomography for Assessment of Pulmonary Hypertension

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a diagnosis or clinical suspicion of pulmonary arterial hypertension (PAH) and with a medical indication for right heart catheterization.
  • Patients evaluated at the Pulmonology Service of InCor-HCFMUSP.
Not Eligible

You will not qualify if you...

  • Pregnancy.
  • Structural heart disease, such as atrial septal defect, ventricular septal defect, or valvular disease.
  • Cardiac arrhythmias.
  • Presence of a cardiac pacemaker or other implantable electronic device.
  • Skin lesions at the thoracic region that would prevent placement of the EIT electrode belt.
  • WHO functional class IV of New York Heart Association (NYHA).
  • Inability to perform a voluntary respiratory pause (apnea) of at least 30 seconds or inability to understand and follow instructions required.
  • Decline to participate by not signing the informed consent form or refusal by the attending medical team.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single day

Participants undergo right heart catheterization and short-term electrical impedance tomography (EIT) monitoring to assess pulmonary artery pressure and hemodynamics.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil, 05403-900

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Research Team

M

Marcelo BP Amato, MD PhD

J

Jade Lara de Melo, PT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism.

L Guérin, F Couturaud, F Parent...

https://pubmed.ncbi.nlm.nih.gov/24898545

2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS).

Stavros V Konstantinides, Guy Meyer, Cecilia Becattini...

https://pubmed.ncbi.nlm.nih.gov/31504429

Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding.

Irene M Lang, Raffaele Pesavento, Diana Bonderman...

https://pubmed.ncbi.nlm.nih.gov/22700839