A Study Of Acute Decompensated Heart Failure

September 2, 2026 updated by: Jared G. Bird, Mayo Clinic

HF-FOCUS: Serial Lung Ultrasound And Peripheral Venous Pressure Monitoring To Enhance The Care Of Hospitalized Patients With Acute Decompensated Heart Failure

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Jared Bird, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects ≥18 years of age
  • Admitted to St. Mary's Hospital Cardiology Progressive Care Unit (Cardiology 1-5 teams)

  • Admission diagnosis of either:

    1. Acute systolic heart failure
    2. Acute on chronic systolic heart failure
    3. Acute diastolic heart failure
    4. Acute on chronic diastolic heart failure
    5. Acute right heart failure
    6. Acute on chronic right heart failure
    7. Failure heart biventricular
  • Able to provide informed consent and willing to undergo daily lung ultrasound examinations during their hospitalization.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Patients undergoing daily lung ultrasound with the results reported to the provider care teams on admission and each morning
Diagnostic test: Lung Ultrasound
Patients will undergo lung ultrasound assessments at hospital admission, daily throughout admission, and at hospital discharge.
Experimental: Group 2
Patients undergoing daily lung ultrasound but the results will be blinded to the provider care teams
Diagnostic test: Lung Ultrasound
Patients will undergo lung ultrasound assessments at hospital admission, daily throughout admission, and at hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days in the hospital
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of re-hospitalized patients
Time Frame: Baseline
Number of patients re-hospitalized will be determined by the number of patients admitted to the hospital post discharge
Baseline
Number of deaths
Time Frame: Baseline
Number of deaths will be determined by number of patient deaths due to any cause
Baseline
Change in effective diuresis
Time Frame: Baseline, up to 90 Days
Diuresis will be measured from a urine sample and calculated by total diuresis in liters/admission weight in kilograms
Baseline, up to 90 Days
Change in diuretic dosing
Time Frame: Baseline, up to 90 Days
Diuretic dosing will be measured in mg
Baseline, up to 90 Days
Change in Lung Congestion
Time Frame: Baseline, up to 90 Days
Lung congestion will be measured using a lung ultrasound and measured as a percentage
Baseline, up to 90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Jared Bird, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 26-000119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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