Status:
RECRUITING
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
Lead Sponsor:
Tempus AI
Collaborating Sponsors:
United Therapeutics
Conditions:
Pulmonary Hypertension
Interstitial Lung Disease (ILD)
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
The goal of this study is to evaluate the use of an ECG-based AI device that may help predict if participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertensio...
Eligibility Criteria
Inclusion
- 18 years or older at the time of consent
- A known diagnosis of interstitial lung disease
- 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, 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)
Key Trial Info
Start Date :
July 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06911632
Start Date
July 23 2025
End Date
July 1 2028
Last Update
December 30 2025
Active Locations (20)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
2
Banner University Medical Center
Phoenix, Arizona, United States, 84006
3
Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
Phoenix, Arizona, United States, 85013
4
National Jewish Health
Denver, Colorado, United States, 80206