AI-analyzed ECG to help find pulmonary hypertension in people with interstitial lung disease

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

MOMENTOUS is a randomized, multi-center trial that enrolls adults with interstitial lung disease who receive a 12-lead ECG analyzed by an AI device. Participants are randomized to have the device results returned to their clinicians or withheld, and those flagged as high risk in the returned-results arm are referred for echocardiography and right heart catheterization. The primary comparison is the rate of new pulmonary hypertension diagnoses over six months between the device-guided arm and standard-of-care control. Standard clinical care remains available to all participants and additional testing may occur if clinicians deem it clinically necessary.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Banner University Medical Center
  Phoenix, Arizona, United States Recruiting
• Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
  Phoenix, Arizona, United States Recruiting
• University of Arkansas
  Little Rock, Arkansas, United States Recruiting
• HCA Riverside Community Hospital
  Riverside, California, United States Recruiting
• National Jewish Health
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Momentous Study
• Email: momentous-study@tempus.com
• Phone: (833) 514-4187

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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.