AI reads your heartbeat to catch silent killer in lung patients
NCT ID NCT06911632
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 900 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
37 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AdventHealth Orlando
RECRUITINGOrlando, Florida, 32803, United States
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Banner University Medical Center
RECRUITINGPhoenix, Arizona, 84006, United States
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Baylor University Medical Center
RECRUITINGDallas, Texas, 75246, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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CHI Health Creighton University Medical Center - Bergan Mercy
RECRUITINGOmaha, Nebraska, 68124, United States
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Community Health Network
RECRUITINGIndianapolis, Indiana, 46237, United States
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Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
RECRUITINGPhoenix, Arizona, 85013, United States
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HCA Riverside Community Hospital
RECRUITINGRiverside, California, 92501, United States
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Hannibal Regional Healthcare System
RECRUITINGHannibal, Missouri, 63401, United States
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Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
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Indiana University Health Methodist Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
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Louisiana State University Health Shreveport
RECRUITINGShreveport, Louisiana, 71102, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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Mercy Hospital Springfield
RECRUITINGSpringfield, Missouri, 65804, United States
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National Jewish Health
RECRUITINGDenver, Colorado, 80206, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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Renown Regional Medical Center
RECRUITINGReno, Nevada, 89502, United States
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Southeastern Research Center
RECRUITINGWinston-Salem, North Carolina, 27103, United States
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Temple University of The Commonwealth System of Higher Education
RECRUITINGPhiladelphia, Pennsylvania, 19140, United States
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Thomas Jefferson University
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44121, United States
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35205, United States
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University of Buffalo
RECRUITINGBuffalo, New York, 14203, United States
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University of Illinois Health
RECRUITINGChicago, Illinois, 60612, United States
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University of Kentucky
RECRUITINGLexington, Kentucky, 40536, United States
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University of Michigan - Michigan Medicine
RECRUITINGAnn Arbor, Michigan, 48109-5360, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Mississippi Medical Center
RECRUITINGJackson, Mississippi, 39216, United States
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University of New Mexico
RECRUITINGAlbuquerque, New Mexico, 87131, United States
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University of Oklahoma
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Tennessee
RECRUITINGKnoxville, Tennessee, 37920, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84103, United States
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
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Weill Cornell University Medical College
RECRUITINGNew York, New York, 10021, United States
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West Virginia University Hospital
RECRUITINGMorgantown, West Virginia, 26505, United States
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Willis Knighton Health
RECRUITINGBossier City, Louisiana, 71111, United States
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Other studies related to the condition(s) this trial covers.
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