Heart Failure With Reduced Ejection FractionPOCUS-HFNCT07828834
Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial
A study testing Point of Care Ultrasound in people with Heart Failure With Reduced Ejection Fraction, run by Corewell Health West at 1 site in United States.
Trial summary
The purpose of the study is to implement point of care ultrasound (POCUS) to generate preliminary, or pilot, data to support a full future POCUS study across multiple Corewell Health outpatient rural facilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Point of Care Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 of age or older at time of consent
- Presenting to an enrolled CH study site with visit type:
- A. PCP - New onset cardiac complaints (e.g., dyspnea on exertion, orthopnea, etc)
- B. Cardiology - New Patient
- Weight ≥ 40kg
- 18 years of age or older at time of verbal consent
- Employed to work at a CH clinic where patient enrollment is planned
Who cannot join
- Documented echocardiogram in the past 3 years
- History of cardiac surgery or congenital heart disease
- O2-dependent pulmonary disease
- BMI ≥40kg/m2
- Pregnancy
- Non-native English speakers who have limited spoken or written understanding of the English language to be able to consent or complete surveys in English
Show all 9Show fewer
- Cognitively impaired individuals with a legally authorized representative or guardian
- Staff Participant Inclusion/Exclusion Criteria
- Deemed inappropriate or ineligible for any reason at PI discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Single-center Randomized Controlled Trial of Software Guided Point-of-care
The purpose of the study is to implement point of care ultrasound (POCUS) to generate preliminary, or pilot, data to support a full future POCUS study across multiple Corewell Health outpatient rural facilities. The study aims to demonstrate feasibility of the procedure utilizing input from the patient, provider, and the clinic staff. Preliminary data will also be used to estimate the magnitude of effect in estimating sample size and power in participants who receive the POCUS procedure versus those who continue with standard of care. Up to 100 participants will be enrolled.
Read the detailed description
The Investogators will harness the power of a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device that can generate an accurate estimate of left ventricular ejection fraction in <5 minutes by medical assistants (MA) with minimal training at a single Corewell Health outpatient practice. Using a randomized clinical trial design in patients with new cardiac symptoms, POCUS-HF will quantify the benefits of using POCUS for heart failure reduced ejection fraction (HFrEF) diagnosis and establishment of Guideline-Directed Medical Therapy (GDMT).
Point of care ultrasound (POCUS) is an adaptation of formal ultrasound technology used to evaluate cardiac structure and function known as transthoracic echocardiography (TTE). TTE is conducted by a trained sonographer and is the initial imaging modality in heart failure diagnoses. POCUS is unique in that it is portable, provides real-time imaging feedback while being relatively inexpensive and accessible to users of variating level of training. POCUS is particularly well positioned to serve the growing HF community throughout Michigan and if performed in the office, may potentially shorten the time to GDMT initiation in new cases of HF. While the investigators posit that a POCUS screening tool will have the greatest impact in rural communities who are already overburdened, the POCUS-HF findings will be applicable in other urbanization levels or geographic regions across the United States, and potentially to other under resourced areas.
One area ideal for intervention is in obtaining accurate measures of left ventricular EF via TTE. In a patient with cardiac symptomatology, the typical workflow includes: 1) initial visit with one's primary care physician including referral to a cardiology specialist and ordering a TTE, 2) TTE 3) cardiology appointment to diagnose HFrEF, and 4) discussion/review of the results with the patient, 5) followed finally by the initiation of GDMT. This process is long and burdensome and is likely particularly more challenging in underserved communities that lack specialists. Thus, TTE acquisition is an ideal place for intervention to shorten this timeline.
There are many innovative components of the POCUS-HF trial including the overarching theoretical framework and the use of guided software within the POCUS device. While POCUS is not a uniquely new concept, the combination of a rigorous POCUS device with real-time software guided turn-by-turn instructions allows for novice capture of LVEF. Another innovation is that the POCUS-HF trial is designed to not only quantitatively, but also qualitatively identify barriers and optimal use cases for POCUS. The Investigators believe this will facilitate the implementation of such screening practices by other institutions and care settings. Future work will aim to define other scenarios where POCUS may be effective, such as routine monitoring of progression in HF patients, or in vascular disease diagnosis settings.
- Being tested
- Point of Care Ultrasound
- Keywords
- HFrEF, POCUS, GDMT, LVEF, Point of Care Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care UltrasoundDevice
Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF
| Study group | Role | What they receive |
|---|---|---|
| POCUS | Active comparator | Left ventricular Ejection fraction is estimated using a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device. Receives: Device: Point of Care Ultrasound |
| Standard of Care | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Participation Rates
Number of patients who agree to study in comparison to number of patients that decline
Measured: 1 year
Medical assistant (MA) training and ability of MAs to conduct accurate POCUS-based estimates of EF
Of the medical assistant's trained for the study how many are successful at the implementation of POCUS for accurate LVEF prediction in comparison to those trained that are unsuccessful at utilizing POCUS for LVEF prediction
Measured: 1 year
Clinic adherence to the protocol
The number of protocol deviations that occur during study timeframe.
Measured: 1 year
Ability to conduct randomization and provide same-day POCUS results
On the day of randomization how many treatment patients receive same day POCUS results in comparison to the treatment patients that don't receive same day results
Measured: 1 year
How many days between HFrEF diagnosis and initiation of GDMT protocols
For both the treatment and non-treatment groups how days between HFeEF diagnosis and the start of GDMT protocols
Measured: 1 year
Implementation and completion rates of patient and provider quantitative and qualitative questionnaires on the burden and benefits of using POCUS in a clinical setting
Number of questionnaires filled out in comparison to the number of blank or missed questionnaires.
Measured: 1 year
Secondary outcomes (7)
Magnitude of effect between pocus treatment and standard of care on the time to HFrEF diagnosis and GDMT initiation.
Quantifying the magnitude/sample size/power needed to estimate enrollment for potential full trial
Measured: 2 years
Difference in patient-level POCUS burden 1-week
Patient level burden will be determined using the Likert-scale (zero burden to burdensome)
Measured: 1-week
Difference in patient-level POCUS burden 3-month
Patient level burden will be determined using the Likert-scale (zero burden to burdensome)
Measured: 3 Months
Healthcare utilization after randomization follow up outpatient visits
Differences in number of follow up outpatient visits
Measured: 1 year
Healthcare utilization after randomization Emergency room visits
Number of patient ER visits
Measured: 1-year
Healthcare utilization after randomization follow up inpatient visits
Number of inpatient visits
Measured: 1-year
Healthcare utilization after randomization GDMT prescriptions
Number of patients prescribed GDMT therapy
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, David Mcnamara, Corewell Health West
- Investigators
- David McNamara, MD, MPh, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828834
- Sponsor's protocol ID
- 2025-1219
- Acronym
- POCUS-HF
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single-center Randomized Controlled Trial of Software Guided Point-of-care
- ClinicalTrials.gov ID
- NCT07828834
- Acronym / sponsor ID
- POCUS-HF / 2025-1219
- Keywords
- HFrEF, POCUS, GDMT, LVEF, Point of Care Ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to implement point of care ultrasound (POCUS) to generate preliminary, or pilot, data to support a full future POCUS study across multiple Corewell Health outpatient rural facilities. The study aims to demonstrate feasibility of the procedure utilizing input from the patient, provider, and the clinic staff. Preliminary data will also be used to estimate the magnitude of effect in estimating sample size and power in participants who receive the POCUS procedure versus those who continue with standard of care. Up to 100 participants will be enrolled.
Detailed description
The Investogators will harness the power of a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device that can generate an accurate estimate of left ventricular ejection fraction in <5 minutes by medical assistants (MA) with minimal training at a single Corewell Health outpatient practice. Using a randomized clinical trial design in patients with new cardiac symptoms, POCUS-HF will quantify the benefits of using POCUS for heart failure reduced ejection fraction (HFrEF) diagnosis and establishment of Guideline-Directed Medical Therapy (GDMT).
Point of care ultrasound (POCUS) is an adaptation of formal ultrasound technology used to evaluate cardiac structure and function known as transthoracic echocardiography (TTE). TTE is conducted by a trained sonographer and is the initial imaging modality in heart failure diagnoses. POCUS is unique in that it is portable, provides real-time imaging feedback while being relatively inexpensive and accessible to users of variating level of training. POCUS is particularly well positioned to serve the growing HF community throughout Michigan and if performed in the office, may potentially shorten the time to GDMT initiation in new cases of HF. While the investigators posit that a POCUS screening tool will have the greatest impact in rural communities who are already overburdened, the POCUS-HF findings will be applicable in other urbanization levels or geographic regions across the United States, and potentially to other under resourced areas.
One area ideal for intervention is in obtaining accurate measures of left ventricular EF via TTE. In a patient with cardiac symptomatology, the typical workflow includes: 1) initial visit with one's primary care physician including referral to a cardiology specialist and ordering a TTE, 2) TTE 3) cardiology appointment to diagnose HFrEF, and 4) discussion/review of the results with the patient, 5) followed finally by the initiation of GDMT. This process is long and burdensome and is likely particularly more challenging in underserved communities that lack specialists. Thus, TTE acquisition is an ideal place for intervention to shorten this timeline.
There are many innovative components of the POCUS-HF trial including the overarching theoretical framework and the use of guided software within the POCUS device. While POCUS is not a uniquely new concept, the combination of a rigorous POCUS device with real-time software guided turn-by-turn instructions allows for novice capture of LVEF. Another innovation is that the POCUS-HF trial is designed to not only quantitatively, but also qualitatively identify barriers and optimal use cases for POCUS. The Investigators believe this will facilitate the implementation of such screening practices by other institutions and care settings. Future work will aim to define other scenarios where POCUS may be effective, such as routine monitoring of progression in HF patients, or in vascular disease diagnosis settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS | Active comparator | Device: Point of Care UltrasoundLeft ventricular Ejection fraction is estimated using a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device. |
| Standard of Care | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older at time of consent
- Presenting to an enrolled CH study site with visit type:
- A. PCP - New onset cardiac complaints (e.g., dyspnea on exertion, orthopnea, etc)
- B. Cardiology - New Patient
- Weight ≥ 40kg
Key exclusion criteria (9 listed)
- Documented echocardiogram in the past 3 years
- History of cardiac surgery or congenital heart disease
- O2-dependent pulmonary disease
- BMI ≥40kg/m2
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of Care UltrasoundPoint of care ultrasound will be used in patients as an early diagnostic tool for HFrEF | Device | POCUS |
Primary outcome
Patient Participation Rates
Time frame: 1 year
Number of patients who agree to study in comparison to number of patients that decline
Medical assistant (MA) training and ability of MAs to conduct accurate POCUS-based estimates of EF
Time frame: 1 year
Of the medical assistant's trained for the study how many are successful at the implementation of POCUS for accurate LVEF prediction in comparison to those trained that are unsuccessful at utilizing POCUS for LVEF prediction
Clinic adherence to the protocol
Time frame: 1 year
The number of protocol deviations that occur during study timeframe.
Ability to conduct randomization and provide same-day POCUS results
Time frame: 1 year
On the day of randomization how many treatment patients receive same day POCUS results in comparison to the treatment patients that don't receive same day results
How many days between HFrEF diagnosis and initiation of GDMT protocols
Time frame: 1 year
For both the treatment and non-treatment groups how days between HFeEF diagnosis and the start of GDMT protocols
Implementation and completion rates of patient and provider quantitative and qualitative questionnaires on the burden and benefits of using POCUS in a clinical setting
Time frame: 1 year
Number of questionnaires filled out in comparison to the number of blank or missed questionnaires.
7 secondary outcomes
Magnitude of effect between pocus treatment and standard of care on the time to HFrEF diagnosis and GDMT initiation.
Time frame: 2 years
Difference in patient-level POCUS burden 1-week
Time frame: 1-week
Difference in patient-level POCUS burden 3-month
Time frame: 3 Months
Healthcare utilization after randomization follow up outpatient visits
Time frame: 1 year
Healthcare utilization after randomization Emergency room visits
Time frame: 1-year
Healthcare utilization after randomization follow up inpatient visits
Time frame: 1-year
Healthcare utilization after randomization GDMT prescriptions
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David McNamara, MD, MPh principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of Care Ultrasound in people with Heart Failure With Reduced Ejection Fraction, run by Corewell Health West at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob M Gonzales, BA,MA (6162670612, Jacob.Gonzales@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Participation Rates (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.