Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial

NCT07828834 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-1219
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF; POCUS; GDMT; LVEF; Point of Care Ultrasound

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Magnitude of effect between pocus treatment and standard of care on the time to HFrEF diagnosis and GDMT initiation.

  2 years

• Difference in patient-level POCUS burden 1-week

  1-week

• Difference in patient-level POCUS burden 3-month

  3 Months

• Healthcare utilization after randomization follow up outpatient visits

  1 year

• Healthcare utilization after randomization Emergency room visits

  1-year

Study Arms (2)

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.

Device: Point of Care Ultrasound

Standard of Care

NO INTERVENTION

Standard of Care

Interventions

Point of Care Ultrasound DEVICE

Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF

POCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• years of age or older at time of verbal consent
• Employed to work at a CH clinic where patient enrollment is planned
• Deemed inappropriate or ineligible for any reason at PI discretion

Sponsors & Collaborators

• Corewell Health West: lead
• Michigan State University: collaborator

Study Sites (1)

Corewell Health West

Grand Rapids, Michigan, 49503, United States

Location

Study Officials

• David McNamara, MD, MPh

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob M Gonzales, BA,MA

CONTACT

6162670612; Jacob.Gonzales@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Imaging Cardiologist

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: September 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)