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Not Yet Recruiting
NCT07828834
Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial
Conditions: Heart Failure With Reduced Ejection Fraction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Corewell Health West
Location: Corewell Health West Grand Rapids Michigan
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07828834). StuddyBuddy aggregates publicly available trial information.