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Could a simple chest strap replace invasive heart tests?

NCT ID NCT07453017

Diagnosis Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a non-invasive device called electrical impedance tomography (EIT) can accurately diagnose pulmonary hypertension, a serious lung condition. Currently, diagnosis requires an invasive procedure called right heart catheterization. Researchers will compare EIT readings to catheterization results in 120 patients to see if EIT can serve as a safer, bedside screening tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Electrical Impedance Tomography (EIT)
What this could lead to
If successful, EIT could become a safe, non-invasive screening tool for pulmonary hypertension, reducing the need for invasive catheterization and enabling earlier diagnosis.
What could go wrong
This is an early diagnostic study, not a treatment trial. EIT may not be accurate enough to replace catheterization, and results may not apply to all patients with pulmonary hypertension.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension pulmonary embolism pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary hypertension Pulmonary thromboembolisms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    São Paulo, São Paulo, 05403-900, Brazil

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