Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by Tempus AI · Updated on 2026-05-04

900

Participants Needed

25

Research Sites

153 weeks

Total Duration

On this page

Sponsors

T

Tempus AI

Lead Sponsor

U

United Therapeutics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of consent
  • Known diagnosis of interstitial lung disease
  • Diffusing capacity for carbon monoxide (DLCO) less than 30% predicted within 3 months prior to consent
  • Willing and able to provide informed consent and complete all study procedures, including echocardiogram and right heart catheterization if needed
Not Eligible

You will not qualify if you...

  • Known diagnosis of pulmonary hypertension or receiving PH-specific therapy
  • Right heart catheterization completed within the past year or ordered but not yet done
  • Left ventricular ejection fraction 40% or less on recent echocardiogram or cardiac MRI
  • Unclassifiable Tempus PH ECG risk result after up to 2 ECG tests
  • Contraindications to right heart catheterization (e.g., pregnancy, mechanical right heart valve)
  • Investigator's decision that risks of right heart catheterization outweigh benefits
  • Severe illness limiting life expectancy to less than 6 months
  • Medical or social factors making the patient unsuitable or unlikely to comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

Banner University Medical Center

Phoenix, Arizona, United States, 84006

Actively Recruiting

3

Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

4

National Jewish Health

Denver, Colorado, United States, 80206

Actively Recruiting

5

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

6

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

7

University of Illinois Health

Chicago, Illinois, United States, 60612

Actively Recruiting

8

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

9

Community Health Network

Indianapolis, Indiana, United States, 46237

Actively Recruiting

10

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

11

Louisiana State University Health Shreveport

Shreveport, Louisiana, United States, 71102

Actively Recruiting

12

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

13

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, United States, 48109-5360

Actively Recruiting

14

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

15

Hannibal Regional Healthcare System

Hannibal, Missouri, United States, 63401

Actively Recruiting

16

CHI Health Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, United States, 68124

Actively Recruiting

17

University of Buffalo

Buffalo, New York, United States, 14203

Actively Recruiting

18

Southeastern Research Center

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

19

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44121

Actively Recruiting

20

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

21

Temple University of The Commonwealth System of Higher Education

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

22

Baylor University Medical Center

Dallas, Texas, United States, 75246

Actively Recruiting

23

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

24

University of Utah

Salt Lake City, Utah, United States, 84103

Actively Recruiting

25

West Virginia University Hospital

Morgantown, West Virginia, United States, 26505

Actively Recruiting

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Research Team

M

Momentous Study

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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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 | DecenTrialz