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AI reads your heartbeat to catch silent killer in lung patients

NCT ID NCT06911632

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This study tests whether an artificial intelligence (AI) tool that analyzes a simple ECG can help doctors find undiagnosed pulmonary hypertension (high blood pressure in the lungs) in people with interstitial lung disease. About 900 adults with severe lung scarring will be randomly assigned to have their doctors see the AI's risk score or not. The goal is to see if the AI leads to more and earlier diagnoses, which could improve treatment and outcomes.

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 900 people

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

Started

Jul 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * 18 years or older at the time of consent * A known diagnosis of interstitial lung disease * Diffusing capacity for carbon monoxide (DLCO) \<30% predicted, collected within 6 months prior to consent * Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required Exclusion Criteria: * A known diagnosis of pulmonary hypertension (including patients prescribed a therapy specifically for pulmonary arterial hypertension (PAH)) * A RHC was completed within the previous 1 year or ordered and not yet completed at the time of consent * LV ejection fraction ≤ 40% on most recent echo or cardiac MRI, if available * Unclassifiable Tempus PH ECG risk result after up to 2 ECG acquisitions * A contraindication to RHC exists (for example, pregnancy or mechanical right heart valve) * Physician decision that if a patient is directed to RHC by the study protocol, the potential risks of RHC outweigh the potential benefits * There is a severe concomitant illness limiting life expectancy to less than 6 months (at the discretion of the investigator) * There is a medical or social factor that makes the patient a poor candidate for the study and/or unlikely to be able to comply with the study protocol or complete study procedures (at the discretion of the investigator)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    37 sites. 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

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Banner University Medical Center

    RECRUITING

    Phoenix, Arizona, 84006, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHI Health Creighton University Medical Center - Bergan Mercy

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46237, United States

  • Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • HCA Riverside Community Hospital

    RECRUITING

    Riverside, California, 92501, United States

  • Hannibal Regional Healthcare System

    RECRUITING

    Hannibal, Missouri, 63401, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Indiana University Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Louisiana State University Health Shreveport

    RECRUITING

    Shreveport, Louisiana, 71102, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mercy Hospital Springfield

    RECRUITING

    Springfield, Missouri, 65804, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Temple University of The Commonwealth System of Higher Education

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44121, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Illinois Health

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Michigan - Michigan Medicine

    RECRUITING

    Ann Arbor, Michigan, 48109-5360, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Tennessee

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84103, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Weill Cornell University Medical College

    RECRUITING

    New York, New York, 10021, United States

  • West Virginia University Hospital

    RECRUITING

    Morgantown, West Virginia, 26505, United States

  • Willis Knighton Health

    RECRUITING

    Bossier City, Louisiana, 71111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.