NCT07453017 Electrical Impedance Tomography for Assessment of Pulmonary Hypertension
| NCT ID | NCT07453017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07453017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07453017 currently recruiting?
Yes, NCT07453017 is actively recruiting participants. Contact the research team at marcelo.amato@hc.fm.usp.br for enrollment information.
Where is the NCT07453017 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07453017 clinical trial?
NCT07453017 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 120 participants.