An interventional study of Point of Care Ultrasound in Heart Failure With Reduced Ejection Fraction, sponsored by Corewell Health West. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Corewell Health West · Not applicable, Interventional, and Diagnostic
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Corewell Health West is the lead sponsor of 16 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion/Exclusion Criteria
Inclusion Criteria:
Exclusion Criteria:
Staff Participant Inclusion/Exclusion Criteria
Inclusion:
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Left ventricular Ejection fraction is estimated using a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device.
Device: Point of Care Ultrasound
Standard of Care
Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF
Patient Participation Rates
Number of patients who agree to study in comparison to number of patients that decline
Time frame: 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
Time frame: 1 year
Clinic adherence to the protocol
The number of protocol deviations that occur during study timeframe.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 1 year
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
Time frame: 2 years
Difference in patient-level POCUS burden 1-week
Patient level burden will be determined using the Likert-scale (zero burden to burdensome)
Time frame: 1-week
Difference in patient-level POCUS burden 3-month
Patient level burden will be determined using the Likert-scale (zero burden to burdensome)
Time frame: 3 Months
Healthcare utilization after randomization follow up outpatient visits
Differences in number of follow up outpatient visits
Time frame: 1 year
Healthcare utilization after randomization Emergency room visits
Number of patient ER visits
Time frame: 1-year
Healthcare utilization after randomization follow up inpatient visits
Number of inpatient visits
Time frame: 1-year
Healthcare utilization after randomization GDMT prescriptions
Number of patients prescribed GDMT therapy
Time frame: 1-year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 12 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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