A Study Of Acute Decompensated Heart Failure

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: Not yet recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Diagnostic test: Lung Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andy Dang; Phone Number: 507-255-7752; Email: dang.phong@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
      • Contact: Andy Dang; Phone Number: 507-255-7752; Email: dang.phong@mayo.edu
      • Principal Investigator: Jared Bird, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Number of patients re-hospitalized will be determined by the number of patients admitted to the hospital post discharge	Baseline
Number of deaths	Number of deaths will be determined by number of patient deaths due to any cause	Baseline
Change in effective diuresis	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	Diuretic dosing will be measured in mg	Baseline, up to 90 Days
Change in Lung Congestion	Lung congestion will be measured using a lung ultrasound and measured as a percentage	Baseline, up to 90 Days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jared Bird, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 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): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 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