Bedside Ultrasound-guided Volume Management and Discharge Timing for Patients With Heart Failure … (NCT07046169) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Bedside Ultrasound-guided Volume Management and Discharge Timing for Patients With Heart Failure During Hospitalization: A Randomized Controlled Trial
China150 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 expe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite rate of heart failure-related rehospitalization or cardiac death within 1 year post-discharge
Timeframe: Assessed at 30 days, 90 days, 6 months, and 1 year post-discharge