NCT06965712

Brief Summary

This study will evaluate whether using bedside ultrasound (also called Point-of-Care Ultrasound or POCUS) can help improve the care of hospitalized patients with decompensated heart failure. Patients will be randomly assigned to two groups: one group will receive ultrasound-guided assessments, and the other group will receive standard clinical evaluations. Researchers will compare the hospital length of stay between the two groups. Ultrasound is a non-invasive, safe, and painless imaging tool. The goal of the study is to find out if ultrasound guidance can lead to shorter hospitalizations and better care for patients with heart failure.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
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

Study Progress76%
Nov 2025Jun 2026

First Submitted

Initial submission to the registry

April 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

April 30, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

Heart FailureDecompensated Heart FailurePoint-of-Care UltrasoundPOCUSHospital Length of StayUltrasound-Guided TherapyLung UltrasoundInferior Vena Cava UltrasoundVolume Status AssessmentReadmission Prevention

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay (LOS)

    Hospital Length of Stay (LOS) will be measured as the number of days from hospital admission to discharge decision. LOS will be compared between the POCUS-guided group and the standard care group.

    From the date of hospital admission to the date of discharge order, assessed up to 30 days.

Secondary Outcomes (1)

  • 30-Day Hospital Readmission Rate

    Within 30 days after hospital discharge

Study Arms (2)

POCUS-Guided Evaluation Group

EXPERIMENTAL

Participants in this group will receive bedside Point-of-Care Ultrasound (POCUS) evaluations of the lungs and inferior vena cava (IVC) twice during hospitalization, once within 24 hours of admission and once prior to discharge. Ultrasound findings will be used to guide fluid management decisions.

Device: Point-of-Care Ultrasound (POCUS)

Standard Clinical Evaluation Group

NO INTERVENTION

Participants in this group will receive standard clinical care without bedside ultrasound guidance. Clinical evaluation and management will be based on physical examination, chest X-rays, laboratory results, and physician judgment.

Interventions

Participants assigned to this group will receive Point-of-Care Ultrasound (POCUS) evaluations of the lungs and inferior vena cava (IVC) during their hospital stay. The ultrasound will be performed twice: once within 24 hours of hospital admission and once prior to hospital discharge. The POCUS findings will be used to guide clinical management decisions regarding fluid status and decongestion therapy in patients with decompensated heart failure. The procedure is non-invasive, radiation-free, and performed at the bedside.

POCUS-Guided Evaluation Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years and older.
  • Hospitalized with a primary diagnosis of decompensated heart failure (left, right, or biventricular).
  • Evidence of volume overload or congestion based on Framingham criteria, clinical examination, elevated proBNP (\>1000 pg/mL), or chest X-ray showing pulmonary edema.
  • Ability to undergo bedside ultrasound evaluation (POCUS) as clinically feasible.
  • Able to provide informed consent.

You may not qualify if:

  • Age under 18 years.
  • Pregnant or breastfeeding women.
  • Terminal illness with life expectancy \< 30 days.
  • Inability to obtain ultrasound images due to body habitus or other technical reasons.
  • Enrollment in another interventional clinical trial that could interfere with the outcomes of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • GUILLERMO IZQUIERDO PRETEL, MD

    Florida International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GUILLERMO IZQUIERDO PRETEL, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to either a Point-of-Care Ultrasound (POCUS)-guided evaluation group or a standard clinical evaluation group. Participants in each group will remain in their assigned arm throughout the duration of their hospital stay. The study is designed as a parallel assignment model without crossover between groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 11, 2025

Study Start

November 24, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

I am running a single-center investigator-initiated study. I am not creating a formal public repository for the individual patient data. At this stage, I am focused on analyzing your results internally (not distributing patient-level data to outside researchers).

Locations