About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ECG-based AI Device - Results Returned to Investigator
- Echocardiogram and Right Heart Catheterization
- ECG-based AI Device - Results Not Returned to Investigator
Treatment groups
Sponsors and collaborators
Tempus AI
Lead sponsor
United Therapeutics
Collaborator