Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial (POCUS-HF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Device: Point of Care Ultrasound

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob M Gonzales, BA,MA; Phone Number: 6162670612; Email: Jacob.Gonzales@corewellhealth.org

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion/Exclusion Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Cognitively impaired individuals with a legally authorized representative or guardian

Staff Participant Inclusion/Exclusion Criteria

Inclusion:

• 18 years of age or older at time of verbal consent
• Employed to work at a CH clinic where patient enrollment is planned

Exclusion:

• Deemed inappropriate or ineligible for any reason at PI discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Active Comparator: POCUS; 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; Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Participation Rates	Number of patients who agree to study in comparison to number of patients that decline	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	1 year
Clinic adherence to the protocol	The number of protocol deviations that occur during study timeframe.	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	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	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
Difference in patient-level POCUS burden 1-week	Patient level burden will be determined using the Likert-scale (zero burden to burdensome)	1-week
Difference in patient-level POCUS burden 3-month	Patient level burden will be determined using the Likert-scale (zero burden to burdensome)	3 Months
Healthcare utilization after randomization follow up outpatient visits	Differences in number of follow up outpatient visits	1 year
Healthcare utilization after randomization Emergency room visits	Number of patient ER visits	1-year
Healthcare utilization after randomization follow up inpatient visits	Number of inpatient visits	1-year
Healthcare utilization after randomization GDMT prescriptions	Number of patients prescribed GDMT therapy	1-year

Collaborators and Investigators

• Sponsor: Corewell Health West
• Collaborators: Michigan State University
• Investigators: Principal Investigator: David McNamara, MD, MPh, Corewell Health West

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: HFrEF; LVEF; GDMT; POCUS; Point of Care Ultrasound
• Other Study ID Numbers: 2025-1219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes