Valvular Heart Disease PatientsIMPROVENCT07756398
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
A study testing Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.) in people with Valvular Heart Disease Patients and Aortic Stenosis, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation
- What is being tested?
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,088 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 1 Dec 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provider (cluster) participants:
- Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients
- Patient panel comprising >50% adults aged 65 years or older
- Sees patients in ambulatory clinic at least 1 day per week on average
- Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel
- Provides written informed consent
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- Patient participants:
- Adults aged 65 to 85 years, inclusive
- Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic
- Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram
Who cannot join
- Provider (cluster) participants:
- Serving in a locum tenens or other temporary capacity
- Unwilling or unable to nominate an AI-POCUS champion from the clinic
- Patient participants:
- Echocardiogram performed within the past 5 years
- At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram
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- History of surgical or transcatheter intervention for aortic or mitral valve disease
- Self-reported structural heart disease
- Significant frailty burden or comorbidities limiting life expectancy to
- 1 year or less
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA contact
Ritika Dhruve, MBBS, MPH contact
United States2 sites
Parkland Health
Dallas, Texas, 75390
Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA, 214-645-7508, dharam.kumbhani@utsouthwestern.edu
Ritika J Dhruve, MBBS, MPH, ritika.dhruve@utsouthwestern.edu
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA, 214-645-7508, dharam.kumbhani@utsouthwestern.edu
Ritika J Dhruve, MBBS, MPH, ritika.dhruve@utsouthwestern.edu
About this study
Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed.
This study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care.
Primary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.
Read the detailed description
Structural heart disease (SHD) - principally degenerative valvular heart disease (VHD) and left ventricular systolic dysfunction (LVSD) - affects an estimated 21.7% of adults aged 65 and older and carries substantial morbidity and mortality, yet detection relies on passive case finding through auscultation and subsequent echocardiography referral. AI-guided point-of-care ultrasound (AI-POCUS) offers a means of systematic screening at the point of routine ambulatory care by operators without formal sonography training.
IMPROVE is a hybrid type 1 effectiveness-implementation, stratified, cluster-randomized trial. The unit of randomization is the provider cluster: each participating primary care or geriatrics physician or advanced practice provider, with their patient panel, constitutes one cluster. Thirty-two clusters are randomized 1:1 to AI-POCUS screening or usual care, stratified by hospital system (UT Southwestern Medical Center and Parkland Health \& Hospital System), with approximately 1,088 patients aged 65-85 enrolled over 24 months.
In intervention clusters, trained clinic staff perform protocolized AI-guided POCUS using the Kosmos Torso-One device, together with a 2 mL NT-proBNP blood draw. Images are reviewed by a blinded echocardiographic core laboratory; participants with at least moderate VHD or LVEF 50% or less are referred for confirmatory transthoracic echocardiography, with all subsequent management at the treating provider's discretion. Usual care clusters receive standard care and are monitored for echocardiography referral within 90 days of the index visit. All echocardiograms performed within 90 days in either arm are interpreted in the core lab in a blinded fashion.
The primary outcome (Aim 1) is a new diagnosis of at least moderate VHD or LVSD confirmed by complete echocardiography within 90 days of screening. Secondary outcomes include downstream care processes and major adverse cardiovascular events over 2 years. Aim 2 evaluates implementation determinants and outcomes - adoption, acceptability, appropriateness, and feasibility - using CFIR and Proctor's taxonomy, through structured workflow observations and semi-structured interviews. The primary analysis is intention-to-treat using a generalized linear mixed model with provider-level random effects.
- Conditions
- Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction
- Being tested
- Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)
- Keywords
- Point-of-care ultrasound, POCUS, Artificial Intelligence, AI-guided imaging, Echocardiography, Screening, Early detection, Heart Failure, Older Adults, Geriatrics, Primary Care, Cluster randomized Trial, Implementation Science
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency, Ventricular Dysfunction, Left, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)Device
A single AI-guided handheld POCUS examination performed by trained clinic staff (medical or certified nursing assistants) during a routine primary care or geriatrics visit. Acquisition is standardized, including parasternal long- and short-axis and apical 3- and 4-chamber views, with 2D imaging, color Doppler, M-mode of the mitral valve, and continuous-wave Doppler of the aortic and mitral valves. Images are transmitted to a central echocardiographic core laboratory, which screens for adequacy; adequate studies are analyzed by pre-specified AI algorithms based on 2017 ASE guidelines, blinded to arm assignment. A positive screen is defined as moderate or greater valvular heart disease or left ventricular ejection fraction of 50% or less. Positive results are communicated to the participant's primary care provider with a recommendation to consider confirmatory TTE; ordering remains at provider discretion, and the study team facilitates completion within 90 days of index visit.
| Study group | Role | What they receive |
|---|---|---|
| AI-POCUS Screening | Experimental | Trained clinic staff perform AI-guided point-of-care ultrasound using the Kosmos Torso-One device on eligible patients during routine primary care or geriatrics visits. Patients with ≥ moderate valvular heart disease or EF ≤50% are referred for confirmatory echocardiography within 90 days. Receives: Device: Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.) |
| Usual Care | No intervention | Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
New diagnosis of ≥ moderate aortic or mitral valvular heart disease or left ventricular systolic dysfunction (ejection fraction ≤50%), confirmed by standard transthoracic echocardiography performed within 90 days of the index clinic visit. Assessed using the disease detection rate (true positives/total number of patients in the study).
Measured: 90 days from index clinic visit
Secondary outcomes (3)
Recall Rate
Proportion of AI-POCUS screening studies requiring further workup, defined as total number of positive screens (true + false positives) divided by total number of patients in the study.
Measured: 90 days from index clinic visit
Referrals to cardiology or cardiac surgery
Proportion of participants with a new referral to cardiology or cardiac surgery, ascertained through electronic health record review.
Measured: 2 years from index clinic visit
Major adverse cardiac events (MACE)
Composite of all-cause mortality, stroke, and cardiovascular hospitalization. Deaths ascertained through EHR review and annual National Death Index query. Stroke and cardiovascular hospitalization ascertained through participant self-report at follow-up, EHR review, and primary discharge diagnoses (ICD-10-CM), with additional confirmation from regional hospital claims data.
Measured: 2 years from index clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart Disease PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified cluster-randomized trial. The unit of randomization is the provider cluster: each participating primary care or geriatrics physician or advanced practice provider, together with their patient panel, constitutes one cluster. Thirty-two clusters are randomized 1:1 to AI-POCUS screening or usual care, stratified by hospital system, with 16 clusters per system (8 per arm). All eligible patients seen by a given provider are assigned to that provider's arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,088 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dharam Kumbhani, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756398
- Sponsor's protocol ID
- STU20260660
- Other IDs
- 95057
- Acronym
- IMPROVE
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared at this time. The study involves vulnerable older adult populations across two clinical sites, and data sharing requires additional privacy and governance review. Data sharing may be considered upon study completion pending IRB approval and execution of appropriate data use agreements.