NCT06911632 · Tempus AI
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
(MOMENTOUS)
What this study is about
MOMENTOUS is a multi-center, randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
ECG-based AI Device - Results Returned to Investigator
An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will be returned to the Investigators.
PROCEDURE
Echocardiogram and Right Heart Catheterization
Echocardiogram- an ultrasound study of the heart and Right Heart Catheterization- a procedure to measure pressures in the heart
DEVICE
ECG-based AI Device - Results Not Returned to Investigator
An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will not be returned to the Investigators.
Primary outcome measures
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.
Time frame: Through study completion, approximately 6 months
Mean pulmonary artery pressure (mPAP) \> 20 mm Hg and pulmonary vascular resistance (PVR) \> 2 Wood units
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Phoenix, Arizona
- Denver, Colorado
- Orlando, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Lexington, Kentucky
- Bossier City, Louisiana
- Shreveport, Louisiana
- Boston, Massachusetts
- Ann Arbor, Michigan
- Minneapolis, Minnesota
And 16 more locations — see the full list below.
Collaborators
United Therapeutics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations