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Portable Ultrasound to Predict Heart Failure Readmission Risk

Primary Purpose

Heart Failure, Patient Readmission

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
The Guthrie Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Primary admission diagnosis is listed as congestive heart failure, with an acute component of decompensation. Age greater than 18 years. Principal residence within the geographic reach of our MIH program. Exclusion Criteria: pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ultrasound

    Arm Description

    Ultrasound at hospital discharge and at follow up in 7-10 days

    Outcomes

    Primary Outcome Measures

    Hospital Readmission
    Hospital readmission within 30 days of discharge

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2023
    Last Updated
    July 31, 2023
    Sponsor
    The Guthrie Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05980533
    Brief Title
    Portable Ultrasound to Predict Heart Failure Readmission Risk
    Official Title
    Utility and Feasibility of Prehospital Portable Ultrasound to Predict Heart Failure Readmission Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Guthrie Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research is to use a handheld ultrasound to assess patients with congestive heart failure (CHF) to see if the ultrasound can help predict readmission to the hospital. The study will include patients who are admitted to the hospital for CHF. Participants will have two ultrasounds at hospital discharge and at a follow up visit.
    Detailed Description
    The purpose of this research is to see if a portable ultrasound can help predict readmission to the hospital for patients who are admitted to the hospital for CHF. The study will enroll patients who take part in Mobile Integrated Healthcare as part of their routine care. Participants will have two ultrasounds. The first ultrasound will be at hospital discharge. Between seven to ten days after hospital discharge participants will be visited at their home in follow-up as the usual standard of care for Mobile Integrated Healthcare. At this visit participants will have a second ultrasound. Participants will be followed for one year for hospital readmission.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Patient Readmission
    Keywords
    Ultrasound

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound
    Arm Type
    Experimental
    Arm Description
    Ultrasound at hospital discharge and at follow up in 7-10 days
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Ultrasound
    Intervention Description
    Ultrasound at hospital discharge and at follow up at 7-10 days
    Primary Outcome Measure Information:
    Title
    Hospital Readmission
    Description
    Hospital readmission within 30 days of discharge
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primary admission diagnosis is listed as congestive heart failure, with an acute component of decompensation. Age greater than 18 years. Principal residence within the geographic reach of our MIH program. Exclusion Criteria: pregnant women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zachary Dewar, MD
    Phone
    570-887-4882
    Email
    Zachary.Dewar@guthrie.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zachary Dewar
    Organizational Affiliation
    The Guthrie Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Portable Ultrasound to Predict Heart Failure Readmission Risk

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