NCT07046169Active, not recruiting
Bedside Ultrasound-guided Volume Management and Discharge Timing for Patients With Heart Failure During Hospitalization: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 22 Jun 2025
- Start date
- Feb 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Pan He
- Diseases
- Heart failure
- NCT number
- NCT07046169
What you commit to
- Study type: Interventional
- Planned participants: 150
- From Feb 2025 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yingtan People's Hospital Coordinator of this site? Confirm its status | Yingtan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.