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
MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)
1 other identifier
interventional
900
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Typical duration for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedStudy Start
First participant enrolled
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
May 4, 2026
April 1, 2026
2.8 years
March 28, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.
Mean pulmonary artery pressure (mPAP) \> 20 mm Hg and pulmonary vascular resistance (PVR) \> 2 Wood units
Through study completion, approximately 6 months
Secondary Outcomes (2)
Proportion of participants receiving a new diagnosis of PH within the Device group compared to the Control group.
Through study completion, approximately 6 months
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the Not high risk Device group.
Through study completion, approximately 6 months
Study Arms (4)
High Risk Device
EXPERIMENTALThe device result will be returned to the treating provider and participants will undergo a study sponsored diagnostic work-up consisting of a transthoracic echocardiogram and an RHC.
Not High Risk Device
EXPERIMENTALThe device result will be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
High Risk Control Arm
OTHERThe device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
Not High Risk Control Arm
OTHERThe device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
Interventions
Echocardiogram- an ultrasound study of the heart and Right Heart Catheterization- a procedure to measure pressures in the heart
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.
An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will be returned to the Investigators.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tempus AIlead
- United Therapeuticscollaborator
Study Sites (25)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Banner University Medical Center
Phoenix, Arizona, 84006, United States
Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
Phoenix, Arizona, 85013, United States
National Jewish Health
Denver, Colorado, 80206, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois Health
Chicago, Illinois, 60612, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Community Health Network
Indianapolis, Indiana, 46237, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Louisiana State University Health Shreveport
Shreveport, Louisiana, 71102, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, 48109-5360, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Hannibal Regional Healthcare System
Hannibal, Missouri, 63401, United States
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, Nebraska, 68124, United States
University of Buffalo
Buffalo, New York, 14203, United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44121, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Temple University of The Commonwealth System of Higher Education
Philadelphia, Pennsylvania, 19140, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84103, United States
West Virginia University Hospital
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- For participants in the Device group, the risk prediction will be returned to the treating provider whereas the providers will be blinded to the risk predictions for participants in the Control group.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 4, 2025
Study Start
July 23, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04