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

NCT07046169 | Active Not Recruiting

• 1 other identifier: POCUS-HF study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Heart Failure (HF); Point-of-Care Ultrasound (POCUS); Inferior Vena Cava (IVC); Pulmonary B-lines

Outcome Measures

Primary Outcomes (1)

• Composite rate of heart failure-related rehospitalization or cardiac death within 1 year post-discharge

  Components: HF rehospitalization: Unplanned admission \>24 hours requiring IV diuretics/vasoactive drugs. Cardiac death: Death from HF, MI, arrhythmia, or unexplained sudden death.

  Assessed at 30 days, 90 days, 6 months, and 1 year post-discharge

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

Standard Clinical Assessment-Guided Management" \*(Discharge based on symptoms/signs alone: Clinical congestion score ≤2 + NYHA class ≤II)

Other: clinical assessment

Intervention Arm - Subgroup A

EXPERIMENTAL

POCUS-Guided Management (Standard Discharge Criteria) (IVC ≥1.8 mm + collapsibility \>50% + B-lines ≤5, alongside clinical criteria)

Other: Ultrasound-Guided Volume Assessment and Decongestion Strategy (UVADS)

Intervention Arm - Subgroup B

EXPERIMENTAL

POCUS-Guided Management (Strict Discharge Criteria) (IVC \<1.8 mm + collapsibility \>50% + B-lines ≤5, alongside clinical criteria)

Other: Ultrasound-Guided Volume Assessment and Decongestion Strategy (UVADS)

Interventions

Ultrasound-Guided Volume Assessment and Decongestion Strategy (UVADS) OTHER

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.

Intervention Arm - Subgroup A; Intervention Arm - Subgroup B

clinical assessment OTHER

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis:
• Hospitalized adults (age 18-90) with acute decompensated HF per ESC 2023 criteria:
• Signs/symptoms (e.g., dyspnea, edema) + objective evidence (e.g., elevated NT-proBNP, imaging).
• Clinical Status:
• NYHA Class II-IV at admission. Systolic BP ≥90 mmHg without vasopressor support.
• Technical Feasibility:
• Able to undergo POCUS assessments (supine positioning, adequate acoustic windows).
• Consent:
• Willing to provide informed consent and complete follow-up.

You may not qualify if:

• Respiratory Confounders Active pneumonia, interstitial lung disease, or lung cancer (may mimic/obscure B-lines).
• COPD with pulmonary hypertension (mPAP ≥25 mmHg) or cor pulmonale (alters IVC dynamics).
• Cardiovascular Instability Cardiogenic shock (SBP \<90 mmHg + lactate \>2 mmol/L requiring inotropes). Acute coronary syndrome (STEMI/NSTEMI) within 7 days (may require alternate therapies).

Sponsors & Collaborators

• Pan He: lead

Study Sites (1)

Yingtan People's Hospital

Yingtan, Jiangxi, 335400, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)