Portable Ultrasound to Predict Heart Failure Readmission... | NCT05980533

Studies
Portable Ultrasound to Predict Heart Failure Readmission Risk

NCT05980533

Sponsor

The Guthrie Clinic

Status

Withdrawn

Last Update Posted

Feb 4, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Heart Failure
Patient Readmission

Interventions

Ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never started and research team member leaving institution

Expanded Access Info

Start Date

Dec 30, 2024Estimated

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Jul 31, 2023

First Submission Date that Met QC Criteria

Jul 31, 2023

First Posted Date

Aug 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2025

Last Update Posted Date

Feb 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound	Experimental	Ultrasound at hospital discharge and at follow up in 7-10 days	Diagnostic Test: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Diagnostic Test	Ultrasound at hospital discharge and at follow up at 7-10 days	Ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital Readmission	Hospital readmission within 30 days of discharge	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Zachary Dewar	The Guthrie Clinic	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided