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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

ConditionsPulmonary HypertensionInterstitial Lung Disease (ILD)
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

This trial does not accept healthy volunteers

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 6 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

Design model

Parallel

Treatments tested in this trial

  • ECG-based AI Device - Results Returned to Investigator

    Device

    An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will be returned to the Investigators.

  • Echocardiogram and Right Heart Catheterization

    Procedure/Surgery

    Echocardiogram- an ultrasound study of the heart and Right Heart Catheterization- a procedure to measure pressures in the heart

  • ECG-based AI Device - Results Not Returned to Investigator

    Device

    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.

Treatment groups

900 Participants
are divided into 4 treatment groups
Group A: High Risk DeviceExperimental treatment 2 interventions
Group B: Not High Risk DeviceExperimental treatment 1 intervention
Group C: High Risk Control ArmOther 1 intervention
Group D: Not High Risk Control ArmOther 1 intervention

Trial outcomes

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

Time frame
Through study completion, approximately 6 months

Secondary outcomes

1

Proportion of participants receiving a new diagnosis of PH within the Device group compared to the Control group.

mPAP \> 20 mm Hg and PVR \> 2 Wood units

Time frame
Through study completion, approximately 6 months
2

Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the Not high risk Device group.

mPAP \> 20 mm Hg and PVR \> 2 Wood units

Time frame
Through study completion, approximately 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tempus AI

Lead sponsor

United Therapeutics

Collaborator

Source ClinicalTrials.gov
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