Using bedside electrical impedance tomography to detect pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center prospective diagnostic study will enroll adults referred for right heart catheterization for suspected or staged pulmonary arterial hypertension. Participants will undergo standard invasive hemodynamic measurement by right heart catheterization followed by short-term EIT monitoring at the bedside, with some subjects receiving a hypertonic saline bolus during a brief respiratory pause to enhance perfusion signal. EIT recordings will be processed offline with algorithms that separate ventilation and perfusion and extract pulsatility-related parameters, which will be compared to invasive measures such as mean pulmonary artery pressure, pulmonary vascular resistance, cardiac output, and stroke volume. The primary goal is to determine how accurately EIT can detect pulmonary hypertension and to explore perfusion/pulsatility indices and diagnostic thresholds for disease severity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Marcelo BP Amato, MD PhD
• Email: marcelo.amato@hc.fm.usp.br
• Phone: +55113061-7361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.