Electrical Impedance Tomography for Assessment of Pulmonary Hypertension

NCT07453017 | Recruiting

• 1 other identifier: 76762824.6.0000.0068
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Hypertension; Pulmonary Thromboembolisms

Keywords

Right Heart Catheterization; Electrical Impedance Tomography (EIT); Pulmonary Vascular Resistance; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure

  Sensitivity (%) of EIT-derived pulsatility amplitude (measured in arbitrary impedance units, ΔZ) to detect pulmonary hypertension defined as mean pulmonary artery pressure (mPAP ≥20 mmHg) measured in mmHg by Right Heart Catheterization (RHC). Diagnostic performance will be assessed using Receiver Operating Characteristic (ROC) curve analysis and area under the curve (AUC).

  At the time of right heart catheterization (baseline, single assessment)

Secondary Outcomes (6)

• Pearson or Spearman Correlation Coefficient (r) Between EIT-Derived Pulsatility Amplitude (ΔZ) and Mean Pulmonary Artery Pressure (mmHg)

  At the time of right heart catheterization

• Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Fractional Area Change (%)

  Immediately after right heart catheterization (single assessment at baseline)

• Correlation Coefficient (r) Between EIT Pulsatility Amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (mm)

  Immediately after right heart catheterization (single assessment at baseline)

• Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Tissue Doppler Systolic Velocity (cm/s)

  immediately after right heart catheterization

• Sensitivity (%), Specificity (%), and Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Detection of Pulmonary Hypertension at Different mPAP Thresholds

  At the time of Right Heart Catheterization.

Study Arms (1)

Diagnostic Arm

EXPERIMENTAL

Patients with suspected or confirmed pulmonary arterial hypertension (PAH) undergoing right heart catheterization will also be monitored with electrical impedance tomography (EIT) around the time of the procedure. EIT-derived signals will be compared with invasive hemodynamic measurements.

Diagnostic Test: Electrical Impedance Tomography (EIT); Procedure: Right Heart Catheterization

Interventions

Electrical Impedance Tomography (EIT) DIAGNOSTIC_TEST

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.

Diagnostic Arm

Right Heart Catheterization PROCEDURE

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.

Diagnostic Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis

Central Study Contacts

Marcelo BP Amato, MD PhD

CONTACT

+55113061-7361; marcelo.amato@hc.fm.usp.br

Jade Lara de Melo, PT

CONTACT

+5534992911757; jade.l.melo.l@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: March 5, 2026
• Study Start: April 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2025-09

Locations

BR (1)