Recruiting

AI DeviceMulti-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension

Sponsor:

Tempus AI

Code:

NCT06911632

Conditions

Pulmonary Hypertension

Interstitial Lung Disease (ILD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ECG-based AI Device - Results Returned to Investigator

Echocardiogram and Right Heart Catheterization

ECG-based AI Device - Results Not Returned to Investigator

Study Details

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.

Conditions

Pulmonary Hypertension

Interstitial Lung Disease (ILD)

Study ID

NCT06911632

Start date

Jul 23, 2025

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 6 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 Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

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.

other: Not High Risk Control Arm

Interventions

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.

Echocardiogram and Right Heart Catheterization

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

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.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Momentous Study

(833) 514-4187 momentous-study@tempus.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Andrea Ford

205-0934-8904 afcook@uabmc.edu

Principal Investigator:

Meenakshi Sridhar, MD

Banner University Medical Center

Recruiting

Phoenix, Arizona, United States, 84006

Contacts

Clinical Research Coordinator

602-521-6400 slmarch@arizona.edu

Principal Investigator:

Sally Suliman, MD

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

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Dominique Robertson

602-406-1295 dominique.robertson900@commonspirit.org

Principal Investigator:

Rajat Walia, MD

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Clinical Research Coordinator

501-214-2407 blee4@uams.edu

Principal Investigator:

William Atchley, MD

HCA Riverside Community Hospital

Recruiting

Riverside, California, United States, 92501

Contacts

Alazzeh

423-737-2281 aalazzeh@pacificpulm.com

Principal Investigator:

Ahmed Alazzeh, MD

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Adrea Arthofer

720-945-8608 arthofera@NJHealth.org

Principal Investigator:

Joshua Solomon, MD

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Kimberly Stark

407-303-9984 kimberly.stark@adventhealth.com

Principal Investigator:

Onix Cantres-Fonseca, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Taryn Holt

312-503-2157 taryn.holt@northwestern.edu

Principal Investigator:

Ruben Mylvaganam, MD

University of Illinois Health

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Dustin Fraidenburg, MD

866-600-2273 dfraiden@uic.edu

Principal Investigator:

Dustin Fraidenburg, MD

Indiana University Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Isabell Mwaura

317-274-0822 imwaura@iu.edu

Principal Investigator:

Onydika Ilonze, MD

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46237

Principal Investigator:

Satish Krishnan, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Srushan Bhaktula

859-323-5000 ssh486@uky.edu

Principal Investigator:

Michael Powers, MD

Willis Knighton Health

Recruiting

Bossier City, Louisiana, United States, 71111

Contacts

Briana Barrow

bbarrow@wkhs.com

Principal Investigator:

Gerardo San Pedro, MD

Louisiana State University Health Shreveport

Recruiting

Shreveport, Louisiana, United States, 71102

Contacts

Teresa Leeth

318-675-5920 teresa.leeth@lsuhs.edu

Principal Investigator:

Afsana Asharaf, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Clinical Research Coordinator

970-846-2343 eharris@bwh.harvard.edu

Principal Investigator:

Aaron Waxman, MD

University of Michigan - Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109-5360

Contacts

Catherine Crombez

734-232-4176 cathercr@med.umich.edu

Principal Investigator:

Elizabeth Belloli, MD

Corewell Health

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Bobbie Lewis

248-551-5958 bobbie.lewis@corewellhealth.org

Principal Investigator:

Enrique Calvo-Ayala, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Mandi DeGrote

612-626-7609 carl1032@umn.edu

Principal Investigator:

Anupam Kumar, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Jaime Brown

jlbrown@umc.edu

Principal Investigator:

Kimberly Dobbs, MD

Hannibal Regional Healthcare System

Recruiting

Hannibal, Missouri, United States, 63401

Contacts

573-629-3926 humam.farah@hannibalclinic.com

Principal Investigator:

Humam Farah, MD

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Tracey Haertling

508-264-5456 nathan.frans@mercy.net

Principal Investigator:

Madhu Pendruthi, MD

CHI Health Creighton University Medical Center - Bergan Mercy

Recruiting

Omaha, Nebraska, United States, 68124

Contacts

Chloe Andersen

402-343-8511 chloe.andersen900@commonspirit.org

Principal Investigator:

Alexander Staller, MD

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Merlino

775-982-7878 amanda.merlino@renown.org

Principal Investigator:

Farah Madhani-Lovely, MD

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Goodale

505-272-6794 LGoodale@salud.unm.edu

Principal Investigator:

Tariq Sallam, MD

University of Buffalo

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Kristopher Clark, MD

Weill Cornell University Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Kimberly Kerr

646-962-2333 kke4001@med.cornell.edu

Principal Investigator:

Robert Kaner, MD

Southeastern Research Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Lauren Miller

336-659-8414 lmiller@southeasternresearchcenter.com

Principal Investigator:

Hassan Yousaf, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44121

Contacts

Jennie Pexa

216-844-3201 jennie.pexa@uhhospitals.org

Principal Investigator:

Maroun Matta, MD

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Maria Mason

405-271-6173 Maria-l-mason@ouhsc.edu

Principal Investigator:

Jad Kebbe, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Mallem

215-955-9181 djamila.mallem@jefferson.edu

Principal Investigator:

Gautam George, MD

Temple University of The Commonwealth System of Higher Education

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Kimberly Selwood

215-707-2291 Kim.Selwood@tuhs.temple.edu

Principal Investigator:

Parth Rali, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Krishna

843-792-1794 georgjam@musc.edu

Principal Investigator:

Rachana Krishna, MD

University of Tennessee

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Herbert

865-305-4893 bherbert@utmck.edu

Principal Investigator:

Isaac Biney, MD

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Brianna Kamran

214-820-6856 Brianna.Kamran@bswhealth.org

Principal Investigator:

Susan Mathai, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Ivan Rosas, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Rosa De Costa

713-441-7182 zsafdar@houstonmethodist.org

Principal Investigator:

Zeenat Safdar, MD

HCA Research Institute - Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Clinical Research Coordinator

210-575-9500 samantha.guerra@hcahealthcare.com

Principal Investigator:

Mahek Shah, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84103

Contacts

Stefanos Lakonios

801-581-5811 stefan.lakonios@hsc.utah.edu

Principal Investigator:

Matthew Glick, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Robin Toft

804-628-4570 robin.toft@vcuhealth.org

Principal Investigator:

Apostolos Perelas, MD

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Chad Glaze

304-293-4661 cglaze@hsc.wvu.edu

Principal Investigator:

Himanshu Deshwal, MD

More Information

Sponsor

Tempus AI

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

Pulmonary Hypertension
Interstitial lung disease (ILD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Tempus AI on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.