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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
MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)
Who can join
Ages 18 and older · All sexes
Full eligibility 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 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)
About the study
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.
What is being tested
- ECG-based AI Device - Results Returned to Investigator (device)
- Echocardiogram and Right Heart Catheterization (procedure)
- ECG-based AI Device - Results Not Returned to Investigator (device)
Sponsor: Tempus AI · Participants: 900 · Started: Jul 23, 2025
Contact the study team
- Momentous Study · Phone: (833) 514-4187
Official record on ClinicalTrials.gov — NCT06911632
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.