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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

NCT06911632 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension
  • Interstitial Lung Disease (ILD)

Interventions

DEVICE

ECG-based AI Device - Results Returned to Investigator

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

PROCEDURE

Echocardiogram and Right Heart Catheterization

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

DEVICE

ECG-based AI Device - Results Not Returned to Investigator

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.

Sponsors & Collaborators

  • Tempus AI

    lead INDUSTRY

  • United Therapeutics

    collaborator INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-23
Primary Completion
2028-05-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911632 on ClinicalTrials.gov