Recruiting

Electrical Impedance Tomography for Assessment of Pulmonary Hypertension

ClinicalTrials.gov IDNCT07453017

PhaseNA

Enrollment120

SponsorUniversity of Sao Paulo General Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pulmonary Hypertension, Pulmonary Thromboembolisms

About this study

Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance. Electrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine. Our hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension

Interventions

Diagnostic Test: Electrical Impedance Tomography (EIT) — Non-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices.
Procedure: Right Heart Catheterization — Standard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures.

Primary outcomes

Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure (At the time of right heart catheterization (baseline, single assessment))

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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 (NYAH).. * Inability to perform a voluntary respiratory pause (apnea) of at least 30 seconds or inability to understand and follow instructions required. * Decline to participate in the study by not signing the informed consent form or refusal by the attending medical team.

Study locations

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo, São Paulo 05403-900 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.