NCT07572955

Brief Summary

The purpose of this study is to examine shorter hospitalization length as well as a reduced rates of recurrent heart failure hospitalization compared to current standard of care in Acute Decompensated Heart Failure. A 1-day reduction in hospital length of stay in unblinded subjects receiving daily HF-FOCUS examinations compared to a blinded standard of care arm.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of days in the hospital

    The number of days a patient is in the hospital will be determined by the day of admission and day of discharge. The day of discharge will be defined as when the consultant physician states that the patient is medically ready for discharge from the hospital.

    Baseline

Secondary Outcomes (5)

  • Number of re-hospitalized patients

    Baseline

  • Number of deaths

    Baseline

  • Change in effective diuresis

    Baseline, up to 90 Days

  • Change in diuretic dosing

    Baseline, up to 90 Days

  • Change in Lung Congestion

    Baseline, up to 90 Days

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients undergoing daily lung ultrasound with the results reported to the provider care teams on admission and each morning

Diagnostic Test: Lung Ultrasound

Group 2

EXPERIMENTAL

Patients undergoing daily lung ultrasound but the results will be blinded to the provider care teams

Diagnostic Test: Lung Ultrasound

Interventions

Lung UltrasoundDIAGNOSTIC_TEST

Patients will undergo lung ultrasound assessments at hospital admission, daily throughout admission, and at hospital discharge.

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects ≥18 years of age
  • Admitted to St. Mary's Hospital Cardiology Progressive Care Unit (Cardiology 1-5 teams)
  • Admission diagnosis of either:
  • Acute systolic heart failure
  • Acute on chronic systolic heart failure
  • Acute diastolic heart failure
  • Acute on chronic diastolic heart failure
  • Acute right heart failure
  • Acute on chronic right heart failure
  • Failure heart biventricular
  • Able to provide informed consent and willing to undergo daily lung ultrasound examinations during their hospitalization.

You may not qualify if:

  • Subjects \<18 years of age
  • Unable to provide informed consent.
  • Unwilling to undergo daily lung ultrasound examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Jared Bird, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
Principal Investigator

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations