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AI-assisted Approach for Pulmonary Hypertension in Interstitial Lung Disease

This study, called MOMENTOUS, is looking at whether an AI (Artificial Intelligence) device can help doctors find pulmonary hypertension (PH) earlier in people who also have interstitial lung disease (ILD). The AI device uses information from a standard heart test called an ECG (electrocardiogram). We want to see if using this AI device leads to more new diagnoses of PH within about 6 months, compared to current usual care. You could join if you are 18 or older, have ILD, and a specific lung function test result (DLCO <30%). The study aims to enroll 900 participants.

Study design
This is a multi-center, randomized study. Participants with ILD will be randomly assigned to either a 'Device' group where doctors see the AI results, or a 'Control' group where doctors do not.
What's involved
You would have a 12-lead ECG. If you are in the 'Device' group and identified as high risk by the AI, you would also have an echocardiogram (heart ultrasound) and a right heart catheterization (a procedure to measure heart pressures).
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured through study completion, which is approximately 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06911632

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
NAAges 18+InterventionalDiagnostic
Tempus AI
~900 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:ECG-based AI Device - Results Returned to InvestigatorEchocardiogram and Right Heart CatheterizationECG-based AI Device - Results Not Returned to Investigator

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.
Measured over Through study completion, approximately 6 months

Conditions

Pulmonary Hypertension
Interstitial Lung Disease (ILD)

Explore related trials

Interstitial Lung DiseasePulmonary Hypertension

Where it's being run

32 sites across 26 states
Arizona2
Illinois2
Indiana2
Louisiana2
Pennsylvania2
Texas2
Alabama1
Colorado1

Who to contact

Momentous Study
[email protected]
(833) 514-4187
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.Through study completion, approximately 6 months

    Mean pulmonary artery pressure (mPAP) \> 20 mm Hg and pulmonary vascular resistance (PVR) \> 2 Wood units