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Clinical Trials in China / NCT07046169
Active, not recruiting Not applicable

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

NCT07046169 · tracked via the Priya Life Science China tracker
Sponsor
Pan He
Phase
Not applicable
Started
2025-02-01
Last updated
2025-07-01

Condition(s) studied

Acute Decompensated Heart Failure (ADHF)

Investigational drug(s) / intervention(s)

Ultrasound-Guided Volume Assessment and Decongestion Strategy (UVADS)clinical assessment

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.

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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). Technical Barriers Subcostal scarring or abdominal dressings preventing IVC visualization. Body habitus (BMI \>40 kg/m²) with persistently poor acoustic windows. Renal/Hepatic Risk AKI (KDIGO Stage 2/3) or dialysis dependence (limits diuretic responsiveness). Cirrhosis (Child-Pugh B/C) (alters volume assessment reliability). Procedural/Logistic Planned cardiac device implantation (e.g., CRT) during hospitalization. Non-adherence (inability to complete follow-up per protocol). Other Exclusions Pregnancy (physiologic IVC changes confound interpretation). Terminal illness (life expectancy \<6 months unrelated to HF).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Yingtan People's Hospital Yingtan Jiangxi

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07046169 on ClinicalTrials.gov ↗ ← All trials in China