Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension

Recruiting now · Not applicable

Conditions studied: Pulmonary Hypertension, Interstitial Lung Disease (ILD)

In brief

MOMENTOUS is a multi-center, randomized study to prospectively evaluate the performance of an ECG-based AI device to predict whether participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension.

Key facts

Study ID

NCT06911632

Run by

Tempus AI

People needed

900

Starts

2025-07-23

Expected to finish

2028-07-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Banner University Medical Center — Phoenix, Arizona, United States (enrolling)
• Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute — Phoenix, Arizona, United States (enrolling)
• National Jewish Health — Denver, Colorado, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Illinois Health — Chicago, Illinois, United States (enrolling)
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• Community Health Network — Indianapolis, Indiana, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Willis Knighton Health — Bossier City, Louisiana, United States (enrolling)
• Louisiana State University Health Shreveport — Shreveport, Louisiana, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan - Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Hannibal Regional Healthcare System — Hannibal, Missouri, United States (enrolling)
• CHI Health Creighton University Medical Center - Bergan Mercy — Omaha, Nebraska, United States (enrolling)
• Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• University of Buffalo — Buffalo, New York, United States (enrolling)
• Southeastern Research Center — Winston-Salem, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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