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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTempus AI

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

900 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Tempus AI

Lead sponsor

United Therapeutics

Collaborator