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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor: Corewell Health West
Study ID: NCT07828834
Status: Not Yet Recruiting

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Conditions

Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed: Sep 18, 2026
Start date: Sep 30, 2026
Status verified: Sep 2026
Primary completion: Sep 30, 2027
Completion: Sep 30, 2028

Study Design

Enrollment: 100 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Arms

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.
No Intervention: Standard of Care
Standard of Care