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Bedside Ultrasound-guided Volume Management and Discharge Timing for Patients With Heart Failure During Hospitalization: A Randomized Controlled Trial

NCT07046169 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-07-01

No results posted yet for this study

Summary

Brief Summary of the POCUS-HF Study

The goal of this clinical trial is to determine whether using bedside ultrasound (POCUS) to guide fluid management and discharge timing can improve outcomes for hospitalized heart failure (HF) patients. The study aims to answer the following questions:

Does POCUS-guided management (using measurements of the inferior vena cava (IVC) and lung B-lines) reduce the risk of rehospitalization and death compared to standard clinical assessment alone? What is the optimal IVC value for determining the safest discharge timing for HF patients in China and Asia?

Researchers will compare two groups:

Intervention group: Patients receive daily POCUS assessments (IVC diameter and lung B-lines) to guide fluid management and discharge decisions.

Control group: Patients receive standard care based on clinical symptoms and signs alone.

Participants will:

Undergo twice-daily POCUS measurements during hospitalization (intervention group only).

Be discharged based on either POCUS criteria (IVC and B-line thresholds) or clinical criteria (control group).

Attend follow-up visits at 7 days, 1 month, 3 months, 6 months, and 1 year after discharge to track rehospitalizations, complications, and survival.

The study hopes to provide evidence that POCUS can help reduce residual fluid overload at discharge, lower rehospitalization rates, and improve long-term outcomes for HF patients.

Conditions

  • Acute Decompensated Heart Failure (ADHF)

Interventions

OTHER

Ultrasound-Guided Volume Assessment and Decongestion Strategy (UVADS)

Unique Combination: Simultaneously tracks IVC collapsibility index (\>50%) + pulmonary B-line counts (≤5) to guide therapy, unlike studies using either metric alone.Thresholds Tested: Compares ESC consensus thresholds (IVC \<2.1cm) vs. exploratory Asian-optimized thresholds (IVC \<1.8cm) in Subgroup B.

OTHER

clinical assessment

Discharge based on symptoms/signs alone: Clinical congestion score ≤2 + NYHA class ≤II

Sponsors & Collaborators

  • Pan He

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-07-31
Completion
2027-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046169 on ClinicalTrials.gov