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Pulmonary HypertensionMOMENTOUSNCT06911632

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

A study testing ECG-based AI Device - Results Returned to Investigator, Echocardiogram and Right Heart Catheterization and ECG-based AI Device - Results Not Returned to Investigator in people with Pulmonary Hypertension and Interstitial Lung Disease (ILD), run by Tempus AI at 40 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ECG-based AI Device - Results Returned to Investigator, Echocardiogram and Right Heart Catheterization and ECG-based AI Device - Results Not Returned to Investigator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
40 sitesUnited States
Study dates
23 Jul 2025to Jul 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

40 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Momentous Study contact

(833) 514-4187

momentous-study@tempus.com

40 sites in 1 country

United States40 sites, 40 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

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

    Tariq Sallam, MD

    Recruiting

  • University of Michigan - Michigan Medicine

    Ann Arbor, Michigan, 48109-5360

    Catherine Crombez, 734-232-4176, cathercr@med.umich.edu

    Elizabeth Belloli, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

    Andrea Ford, 205-0934-8904, afcook@uabmc.edu

    Meenakshi Sridhar, MD

    Recruiting

  • Willis Knighton Health

    Bossier City, Louisiana, 71111

    Briana Barrow, bbarrow@wkhs.com

    Gerardo San Pedro, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Clinical Research Coordinator, 970-846-2343, eharris@bwh.harvard.edu

    Aaron Waxman, MD

    Recruiting

  • University of Buffalo

    Buffalo, New York, 14203

    Kristopher Clark, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Krishna, 843-792-1794, georgjam@musc.edu

    Rachana Krishna, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Taryn Holt, 312-503-2157, taryn.holt@northwestern.edu

    Ruben Mylvaganam, MD

    Recruiting

  • University of Illinois Health

    Chicago, Illinois, 60612

    Dustin Fraidenburg, MD, 866-600-2273, dfraiden@uic.edu

    Dustin Fraidenburg, MD

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44121

    Jennie Pexa, 216-844-3201, jennie.pexa@uhhospitals.org

    Maroun Matta, MD

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

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

    Susan Mathai, MD

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    Adrea Arthofer, 720-945-8608, arthofera@NJHealth.org

    Joshua Solomon, MD

    Recruiting

  • Hannibal Regional Healthcare System

    Hannibal, Missouri, 63401

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

    Humam Farah, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Ivan Rosas, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Rosa De Costa, 713-441-7182, zsafdar@houstonmethodist.org

    Zeenat Safdar, MD

    Recruiting

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

    Isabell Mwaura, 317-274-0822, imwaura@iu.edu

    Onydika Ilonze, MD

    Recruiting

  • Community Health Network

    Indianapolis, Indiana, 46237

    Satish Krishnan, MD

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Jaime Brown, jlbrown@umc.edu

    Kimberly Dobbs, MD

    Recruiting

  • University of Tennessee

    Knoxville, Tennessee, 37920

    Herbert, 865-305-4893, bherbert@utmck.edu

    Isaac Biney, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Srushan Bhaktula, 859-323-5000, ssh486@uky.edu

    Michael Powers, MD

    Recruiting

  • University of Arkansas

    Little Rock, Arkansas, 72205

    Clinical Research Coordinator, 501-214-2407, blee4@uams.edu

    William Atchley, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Mandi DeGrote, 612-626-7609, carl1032@umn.edu

    Anupam Kumar, MD

    Recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia, 26505

    Chad Glaze, 304-293-4661, cglaze@hsc.wvu.edu

    Himanshu Deshwal, MD

    Recruiting

  • Weill Cornell University Medical College

    New York, New York, 10021

    Kimberly Kerr, 646-962-2333, kke4001@med.cornell.edu

    Robert Kaner, MD

    Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

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

    Jad Kebbe, MD

    Recruiting

  • CHI Health Creighton University Medical Center - Bergan Mercy

    Omaha, Nebraska, 68124

    Chloe Andersen, 402-343-8511, chloe.andersen900@commonspirit.org

    Alexander Staller, MD

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32803

    Kimberly Stark, 407-303-9984, kimberly.stark@adventhealth.com

    Onix Cantres-Fonseca, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

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

    Gautam George, MD

    Recruiting

  • Temple University of The Commonwealth System of Higher Education

    Philadelphia, Pennsylvania, 19140

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

    Parth Rali, MD

    Recruiting

  • Banner University Medical Center

    Phoenix, Arizona, 84006

    Clinical Research Coordinator, 602-521-6400, slmarch@arizona.edu

    Sally Suliman, MD

    Recruiting

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

    Phoenix, Arizona, 85013

    Dominique Robertson, 602-406-1295, dominique.robertson900@commonspirit.org

    Rajat Walia, MD

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

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

    Farah Madhani-Lovely, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Robin Toft, 804-628-4570, robin.toft@vcuhealth.org

    Apostolos Perelas, MD

    Recruiting

  • HCA Riverside Community Hospital

    Riverside, California, 92501

    Alazzeh, 423-737-2281, aalazzeh@pacificpulm.com

    Ahmed Alazzeh, MD

    Recruiting

  • Corewell Health

    Royal Oak, Michigan, 48073

    Bobbie Lewis, 248-551-5958, bobbie.lewis@corewellhealth.org

    Enrique Calvo-Ayala, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84103

    Stefanos Lakonios, 801-581-5811, stefan.lakonios@hsc.utah.edu

    Matthew Glick, MD

    Recruiting

  • HCA Research Institute - Methodist Hospital

    San Antonio, Texas, 78229

    Clinical Research Coordinator, 210-575-9500, samantha.guerra@hcahealthcare.com

    Mahek Shah, MD

    Recruiting

  • Louisiana State University Health Shreveport

    Shreveport, Louisiana, 71102

    Teresa Leeth, 318-675-5920, teresa.leeth@lsuhs.edu

    Afsana Asharaf, MD

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Tracey Haertling, 508-264-5456, nathan.frans@mercy.net

    Madhu Pendruthi, MD

    Recruiting

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

    Lauren Miller, 336-659-8414, lmiller@southeasternresearchcenter.com

    Hassan Yousaf, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
ECG-based AI Device - Results Returned to Investigator, Echocardiogram and Right Heart Catheterization, ECG-based AI Device - Results Not Returned to Investigator
Keywords
Pulmonary Hypertension, Interstitial lung disease (ILD)
Medical subject headings
Hypertension, Pulmonary, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECG-based AI Device - Results Returned to InvestigatorDevice

    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 CatheterizationProcedure or 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 InvestigatorDevice

    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.

Study groups in NCT06911632
Study groupRoleWhat they receive
High Risk DeviceExperimentalThe 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.
Receives: Device: ECG-based AI Device - Results Returned to Investigator; Procedure: Echocardiogram and Right Heart Catheterization
Not High Risk DeviceExperimentalThe 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.
Receives: Device: ECG-based AI Device - Results Returned to Investigator
High Risk Control ArmOtherThe 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.
Receives: Device: ECG-based AI Device - Results Not Returned to Investigator
Not High Risk Control ArmOtherThe 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.
Receives: Device: ECG-based AI Device - Results Not Returned to Investigator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, approximately 6 months

Secondary outcomes (2)

  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

    Measured: 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

    Measured: Through study completion, approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start23 Jul 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
An ECG-based AI device, will provide a prediction of a participant's risk of having undiagnosed pulmonary hypertension. Participants with a high risk prediction in the Device group will undergo a transthoracic echocardiogram and a right heart catheterization (RHC). All other participants will receive standard of care treatment.
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911632
Sponsor's protocol ID
TP-CA-008
Acronym
MOMENTOUS
Status last verified
Oct 2026
First submitted
28 Mar 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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