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

MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)

Not applicable Interventional Tempus AI · NCT06911632

This project tests whether an AI-read 12-lead ECG can help doctors find hidden pulmonary hypertension in adults with interstitial lung disease.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years and up
SexAll
SponsorTempus AI Industry-sponsored
Locations25 sites (Birmingham, Alabama and 24 other locations)
Trial IDNCT06911632 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with a known diagnosis of interstitial lung disease, DLCO <30% predicted within 3 months, no prior pulmonary hypertension diagnosis, and ability to consent and undergo echo/RHC are the ideal candidates.

Not a fit: Patients with an existing pulmonary hypertension diagnosis, a recent right heart catheterization within the past year, left ventricular ejection fraction ≤40%, contraindications to RHC, or unclassifiable ECG results are unlikely to benefit from the protocolized device-driven testing.

Why it matters

Potential benefit: If successful, this approach could increase earlier detection of pulmonary hypertension in people with ILD, enabling timelier treatment and management.

How similar studies have performed: Early pilot work and other AI-ECG research have shown promising signals for detecting cardiac conditions including possible pulmonary hypertension, but large randomized evidence for this specific use is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 3 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 this trial is running

Birmingham, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary HypertensionInterstitial Lung DiseaseInterstitial lung disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.