Pulmonary HypertensionNCT07453017
Electrical Impedance Tomography for Assessment of Pulmonary Hypertension
A study testing Electrical Impedance Tomography (EIT) and Right Heart Catheterization in people with Pulmonary Hypertension and Pulmonary Thromboembolisms, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Thromboembolisms
- What is being tested?
- Electrical Impedance Tomography (EIT) and Right Heart Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-900
Marcelo BP Amato, MD, PhD, +55113061-7361, marcelo.amato@hc.fm.usp.br
Jade Lara de Melo, PT, +5534992911757, jade.l.melo.l@gmail.com
About this study
Official title: Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization
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
Read the detailed description
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.
- Conditions
- Pulmonary Hypertension, Pulmonary Thromboembolisms
- Being tested
- Electrical Impedance Tomography (EIT), Right Heart Catheterization
- Keywords
- Right Heart Catheterization, Electrical Impedance Tomography (EIT), Pulmonary Vascular Resistance, Cardiac Output
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Right Heart CatheterizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Electrical Impedance Tomography (EIT); Procedure: Right Heart Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: At the time of right heart catheterization
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Fractional Area Change (%)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Fractional Area Change (%, measured in millimeters by transthoracic echocardiography).
Measured: Immediately after right heart catheterization (single assessment at baseline)
Correlation Coefficient (r) Between EIT Pulsatility Amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (mm)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (TAPSE, measured in millimeters by transthoracic echocardiography).
Measured: Immediately after right heart catheterization (single assessment at baseline)
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Tissue Doppler Systolic Velocity (cm/s)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tissue Doppler Systolic Velocity (cm/s). (S', measured in millimeters by transthoracic echocardiography).
Measured: 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
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.
Measured: At the time of Right Heart Catheterization.
Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Classification of Pulmonary Hypertension Severity
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.
Measured: At the time of right heart catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start26 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453017
- Sponsor's protocol ID
- 76762824.6.0000.0068
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.
PubMed 19491438Barber DC, Brown BH. Applied potential tomography. J Br Interplanet Soc. 1989 Aug;42(7):391-3.
PubMed 11540235Eyuboglu BM, Brown BH, Barber DC, Seagar AD. Localisation of cardiac related impedance changes in the thorax. Clin Phys Physiol Meas. 1987;8 Suppl A:167-73. doi: 10.1088/0143-0815/8/4a/021.
PubMed 3568566Fagerberg A, Stenqvist O, Aneman A. Monitoring pulmonary perfusion by electrical impedance tomography: an evaluation in a pig model. Acta Anaesthesiol Scand. 2009 Feb;53(2):152-8. doi: 10.1111/j.1399-6576.2008.01847.x.
PubMed 19175575Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
PubMed 24898545Jenkins DP, Madani M, Mayer E, Kerr K, Kim N, Klepetko W, Morsolini M, Dartevelle P. Surgical treatment of chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Mar;41(3):735-42. doi: 10.1183/09031936.00058112. Epub 2012 Nov 8.
PubMed 23143539Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
PubMed 31504429Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
PubMed 22700839Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
PubMed 21969018Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
PubMed 14693669Vonk-Noordegraaf A 2nd, Janse A, Marcus JT, Bronzwaer JG, Postmust PE, Faes TJ, De Vries PM. Determination of stroke volume by means of electrical impedance tomography. Physiol Meas. 2000 May;21(2):285-93. doi: 10.1088/0967-3334/21/2/308.
PubMed 10847195Zadehkoochak M, Blott BH, Hames TK, George RF. Pulmonary perfusion and ventricular ejection imaging by frequency domain filtering of EIT (electrical impedance tomography) images. Clin Phys Physiol Meas. 1992;13 Suppl A:191-6. doi: 10.1088/0143-0815/13/a/037.
PubMed 1587100Berger RM, Beghetti M, Humpl T, Raskob GE, Ivy DD, Jing ZC, Bonnet D, Schulze-Neick I, Barst RJ. Clinical features of paediatric pulmonary hypertension: a registry study. Lancet. 2012 Feb 11;379(9815):537-46. doi: 10.1016/S0140-6736(11)61621-8. Epub 2012 Jan 11.
PubMed 22240409Barber DC. Quantification in impedance imaging. Clin Phys Physiol Meas. 1990;11 Suppl A:45-56. doi: 10.1088/0143-0815/11/4a/306.
PubMed 2286047
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pulmonary Artery Pressure and Hemodynamic Measurements by Electrical Impedance Tomography and Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT07453017
- Acronym / sponsor ID
- 76762824.6.0000.0068
- Conditions
- Pulmonary Hypertension, Pulmonary Thromboembolisms
- Keywords
- Right Heart Catheterization, Electrical Impedance Tomography (EIT), Pulmonary Vascular Resistance, Cardiac Output
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Arm | Experimental | Diagnostic Test: Electrical Impedance Tomography (EIT), Procedure: Right Heart CatheterizationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Diagnostic Arm |
| Right Heart CatheterizationStandard 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. | Procedure or surgery | Diagnostic Arm |
Primary outcome
Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure
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).
6 secondary outcomes
Pearson or Spearman Correlation Coefficient (r) Between EIT-Derived Pulsatility Amplitude (ΔZ) and Mean Pulmonary Artery Pressure (mmHg)
Time frame: At the time of right heart catheterization
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Fractional Area Change (%)
Time frame: Immediately after right heart catheterization (single assessment at baseline)
Correlation Coefficient (r) Between EIT Pulsatility Amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (mm)
Time frame: Immediately after right heart catheterization (single assessment at baseline)
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Tissue Doppler Systolic Velocity (cm/s)
Time frame: 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
Time frame: At the time of Right Heart Catheterization.
Area Under the ROC Curve (AUC) of EIT Pulsatility Amplitude for Classification of Pulmonary Hypertension Severity
Time frame: At the time of right heart catheterization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 19491438Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088/0967-3334/30/6/S03. Epub 2009 Jun 2.
- Background: PubMed 11540235Barber DC, Brown BH. Applied potential tomography. J Br Interplanet Soc. 1989 Aug;42(7):391-3.
- Background: PubMed 3568566Eyuboglu BM, Brown BH, Barber DC, Seagar AD. Localisation of cardiac related impedance changes in the thorax. Clin Phys Physiol Meas. 1987;8 Suppl A:167-73. doi: 10.1088/0143-0815/8/4a/021.
- Background: PubMed 19175575Fagerberg A, Stenqvist O, Aneman A. Monitoring pulmonary perfusion by electrical impedance tomography: an evaluation in a pig model. Acta Anaesthesiol Scand. 2009 Feb;53(2):152-8. doi: 10.1111/j.1399-6576.2008.01847.x.
- Background: PubMed 24898545Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
- Background: PubMed 23143539Jenkins DP, Madani M, Mayer E, Kerr K, Kim N, Klepetko W, Morsolini M, Dartevelle P. Surgical treatment of chronic thromboembolic pulmonary hypertension. Eur Respir J. 2013 Mar;41(3):735-42. doi: 10.1183/09031936.00058112. Epub 2012 Nov 8.
- Background: PubMed 31504429Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Background: PubMed 22700839Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013 Feb;41(2):462-8. doi: 10.1183/09031936.00049312. Epub 2012 Jun 14.
- Background: PubMed 21969018Pepke-Zaba J, Delcroix M, Lang I, Mayer E, Jansa P, Ambroz D, Treacy C, D'Armini AM, Morsolini M, Snijder R, Bresser P, Torbicki A, Kristensen B, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Hamid AM, Jais X, Simonneau G. Chronic thromboembolic pulmonary hypertension (CTEPH): results from an international prospective registry. Circulation. 2011 Nov 1;124(18):1973-81. doi: 10.1161/CIRCULATIONAHA.110.015008. Epub 2011 Oct 3.
- Background: PubMed 14693669Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
- Background: PubMed 10847195Vonk-Noordegraaf A 2nd, Janse A, Marcus JT, Bronzwaer JG, Postmust PE, Faes TJ, De Vries PM. Determination of stroke volume by means of electrical impedance tomography. Physiol Meas. 2000 May;21(2):285-93. doi: 10.1088/0967-3334/21/2/308.
- Background: PubMed 1587100Zadehkoochak M, Blott BH, Hames TK, George RF. Pulmonary perfusion and ventricular ejection imaging by frequency domain filtering of EIT (electrical impedance tomography) images. Clin Phys Physiol Meas. 1992;13 Suppl A:191-6. doi: 10.1088/0143-0815/13/a/037.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography (EIT) and Right Heart Catheterization in people with Pulmonary Hypertension and Pulmonary Thromboembolisms, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo BP Amato, MD PhD (+55113061-7361, marcelo.amato@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure (time frame: At the time of right heart catheterization (baseline, single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07453017, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.