NCT06911632 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
| NCT ID | NCT06911632 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tempus AI |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2025-07-23 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06911632 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06911632 currently recruiting?
Yes, NCT06911632 is actively recruiting participants. Contact the research team at momentous-study@tempus.com for enrollment information.
Where is the NCT06911632 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Phoenix, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT06911632 clinical trial?
NCT06911632 is sponsored by Tempus AI. The trial plans to enroll 900 participants.