Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-900, Brazil
Location status: Recruiting
Location contact
Jade Lara de Melo, PT
CONTACT
Marcelo BP Amato, MD, PhD
CONTACT
NCT Number: NCT07453017
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
São Paulo, 05403-900, Brazil
Location status: Recruiting
Jade Lara de Melo, PT
CONTACT
Marcelo BP Amato, MD, PhD
CONTACT
This single-center, prospective diagnostic study is designed to investigate whether EIT-derived measures correlate with invasive hemodynamic parameters obtained by RHC. Adult patients referred for RHC due to suspected PAH or for disease staging will undergo standard catheterization, followed by short-term EIT monitoring. Some patients will additionally receive a hypertonic saline injection during a respiratory pause to enhance the perfusion signal. All EIT data will be processed offline using dedicated algorithms to separate ventilation and perfusion signals and to extract pulsatility-related parameters (e.g., amplitude, area, inflection points). These values will then be compared with RHC-derived hemodynamic measures such as mean pulmonary artery pressure (mPAP), pulmonary vascular resistance (PVR), cardiac output (CO), and stroke volume (SV).
The primary outcome of this study is to determine the diagnostic accuracy of EIT for detecting pulmonary hypertension, aiming at high sensitivity and clinical utility as a screening tool prior to invasive catheterization. Secondary analyses will include exploration of additional EIT-derived perfusion and pulsatility indices, assessment of diagnostic thresholds for different levels of PAH severity, and evaluation of prognostic implications.
Risks associated with participation are minimal, as EIT is non-invasive and safe. The risks of RHC are those inherent to the procedure and are independent of the study. While no direct benefit is expected for individual participants, the findings may provide important insights into the use of EIT as a less invasive diagnostic strategy for PAH, with potential implications for clinical practice and patient care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: At the time of right heart catheterization (baseline, single assessment)
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).
Time frame: At the time of right heart catheterization
Correlation coefficient (r) between EIT-derived pulsatility amplitude (ΔZ, arbitrary impedance units) and mean pulmonary artery pressure (mmHg), pulmonary vascular resistance (Wood units), cardiac output (L/min), and stroke volume (mL), all measured invasively by Right Heart Catheterization.
Time frame: Immediately after right heart catheterization (single assessment at baseline)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Fractional Area Change (%, measured in millimeters by transthoracic echocardiography).
Time frame: Immediately after right heart catheterization (single assessment at baseline)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (TAPSE, measured in millimeters by transthoracic echocardiography).
Time frame: immediately after right heart catheterization
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tissue Doppler Systolic Velocity (cm/s). (S', measured in millimeters by transthoracic echocardiography).
Time frame: At the time of Right Heart Catheterization.
Diagnostic performance of EIT-derived pulsatility amplitude (ΔZ) to detect pulmonary hypertension defined by mean pulmonary artery pressure thresholds of ≥20 mmHg and ≥40 mmHg measured by Right Heart Catheterization.
Time frame: At the time of right heart catheterization
Ability of EIT-derived pulsatility amplitude (ΔZ) to classify pulmonary hypertension severity categories defined by mean pulmonary artery pressure ranges (20-40 mmHg vs >40 mmHg), measured invasively by Right Heart Catheterization.
Contact information is provided by the study sponsor or research team.
Jade Lara de Melo, PT
CONTACT
Marcelo BP Amato, MD PhD
CONTACT
University of Sao Paulo General Hospital
Other
Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization
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