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 (MOMENTOUS)

April 30, 2026 updated by: Tempus AI

MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to evaluate the use of an ECG-based AI device that may help predict if participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension (PH). The study seeks to determine whether use of the device increases the rate of new PH diagnoses over a period of 6 months as compared to current standard of care.

The study will recruit participants with ILD from lung disease clinics who will each receive a 12-lead ECG (a test that measures the electrical activity of the heart) following consent. The device will analyze the 12-lead ECG results to identify participants that are at high risk of having undiagnosed PH.

Participants will be randomly assigned to either the Device or Control group. For participants in the Device group investigators will receive the results of the device. In the Control group investigators will not receive the results of the device. Additionally, participants in the Device group identified as "high risk" by the device will receive a transthoracic echocardiogram and a right heart catheterization (RHC). Participants in the Device group who are not high risk and all participants in the Control group will not receive these additional tests as part of the study, but will receive standard of care treatment as determined by their physicians, which may include an echocardiogram or RHC if clinically indicated.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Meenakshi Sridhar, MD
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
        • Principal Investigator:
          • Rajat Walia, MD
        • Contact:
      • Phoenix, Arizona, United States, 84006
        • Recruiting
        • Banner University Medical Center
        • Principal Investigator:
          • Sally Suliman, MD
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health
        • Principal Investigator:
          • Joshua Solomon, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Onix Cantres-Fonseca, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Ruben Mylvaganam, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Health
        • Principal Investigator:
          • Dustin Fraidenburg, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Onydika Ilonze, MD
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Community Health Network
        • Principal Investigator:
          • Satish Krishnan, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University Of Kentucky
        • Contact:
        • Principal Investigator:
          • Michael Powers, MD
    • Louisiana
      • Shreveport, Louisiana, United States, 71102
        • Recruiting
        • Louisiana State University Health Shreveport
        • Contact:
        • Principal Investigator:
          • Afsana Asharaf, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Aaron Waxman, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5360
        • Recruiting
        • University of Michigan - Michigan Medicine
        • Principal Investigator:
          • Elizabeth Belloli, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Anupam Kumar, MD
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Recruiting
        • Hannibal Regional Healthcare System
        • Principal Investigator:
          • Humam Farah, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • CHI Health Creighton University Medical Center - Bergan Mercy
        • Contact:
        • Principal Investigator:
          • Alexander Staller, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University of Buffalo
        • Principal Investigator:
          • Kristopher Clark, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cleveland, Ohio, United States, 44121
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Maroun Matta, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Contact:
        • Principal Investigator:
          • Jad Kebbe, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University of The Commonwealth System of Higher Education
        • Principal Investigator:
          • Parth Rali, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center
        • Principal Investigator:
          • Susan Mathai, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Ivan Rosas, MD
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Matthew Glick, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • West Virginia University Hospital
        • Contact:
        • Principal Investigator:
          • Himanshu Deshwal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Risk Device
The device result will be returned to the treating provider and participants will undergo a study sponsored diagnostic work-up consisting of a transthoracic echocardiogram and an RHC.
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
Experimental: Not High Risk Device
The device result will be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
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.
Other: High Risk Control Arm
The device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
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.
Other: Not High Risk Control Arm
The device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.
Time Frame: Through study completion, approximately 6 months
Mean pulmonary artery pressure (mPAP) > 20 mm Hg and pulmonary vascular resistance (PVR) > 2 Wood units
Through study completion, approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants receiving a new diagnosis of PH within the Device group compared to the Control group.
Time Frame: Through study completion, approximately 6 months
mPAP > 20 mm Hg and PVR > 2 Wood units
Through study completion, approximately 6 months
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the Not high risk Device group.
Time Frame: Through study completion, approximately 6 months
mPAP > 20 mm Hg and PVR > 2 Wood units
Through study completion, approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tempus AI

Collaborators

United Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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