POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
Starting soon · Phase 2/Phase 3
Conditions studied: Acute Heart Failure (AHF), Congestive Heart Failure Acute, Diuretic Effect, Lung Ultrasonography Score, Ultrasonography, Doppler, Point-of-care Ultrasound (POCUS)
In brief
Acute decompensated heart failure (ADHF) is a frequent cause of hospitalization and is associated with high morbidity and mortality. Congestion is the primary pathophysiological mechanism leading to clinical deterioration and hospitalization in ADHF. Diuretics remain the cornerstone of treatment for most ADHF phenotypes; however, evidence regarding optimal strategies to guide diuretic therapy during the decongestion process is limited. Recently, point-of-care ultrasound (POCUS) has emerged as a promising tool to support clinical assessment in ADHF, improving diagnostic accuracy, prognostication, and pre-discharge evaluation. Nevertheless, the role of POCUS in guiding therapeutic management in ADHF remains uncertain. To specifically assess congestion in patients with ADHF, a pragmatic POCUS-based score, the Dynamic Ultrasound Congestion Score (DUCS), was developed. DUCS integrates lung ultrasound and Venous Excess Ultrasound (VExUS) to dynamically evaluate congestion severity, treatment response, and therapeutic goals during ADHF management. Observational data suggest that DUCS is associated with in-hospital outcomes and short-term prognosis, and correlates with markers of decongestion such as urinary output and weight loss. This study is a randomized, single-center, single-blind clinical trial designed to evaluate whether a DUCS-guided POCUS strategy improves clinical and decongestion outcomes compared with standard of care. Eligible patients hospitalized due to ADHF will be randomized within 48 hours of admission to one of two groups: (1) diuretic treatment guided by institutional standard-of-care combined with information from the EVEREST congestion score assessment and guideline-based treatment recommendations; or (2) diuretic treatment guided by serial DUCS-based POCUS assessments used to inform diuretic adjustment recommendations. Participants in both groups will undergo evaluations at baseline (day 1), day 2, day 3 and day 5, including clinical data collection, physical examination using the EVEREST congestion score, and standardized DUCS-based POCUS assessments. Outcomes to be assessed include in-hospital mortality, length of hospital stay, decongestion parameters, and changes in biomarkers.
Key facts
- Study ID
- NCT07469722
- Run by
- Hospital de Clinicas de Porto Alegre
- People needed
- 128
- Starts
- 2026-03-23
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women aged 18 years or older.
- Diagnosis of acute decompensated heart failure (ADHF) with left ventricular ejection fraction <50%, presenting with symptoms (dyspnea, orthopnea, fatigue) and/or signs (pulmonary crackles, peripheral edema, jugular venous distension, hepatomegaly, hepatojugular reflux) of decompensated heart failure.
- Brain natriuretic peptide (BNP) ≥ 300 pg/mL.
- Signs of systemic and/or pulmonary congestion on POCUS, defined as DUCS ≥ 3 points.
- Time from hospital admission ≤ 48 hours.
- Signed informed consent.
You may not qualify if…
- Patients under evaluation for heart transplantation or with prior heart transplantation.
- Acute coronary syndrome as the primary cause of hospitalization.
- Evidence of uncontrolled infection.
- Cardiac surgery or percutaneous coronary or structural cardiac intervention within the previous 30 days.
- Signs of hypoperfusion, defined as any of the following: mean arterial pressure < 60 mmHg, capillary refill time > 4 seconds, arterial lactate > 2 mmol/L or venous lactate > 2.5 mmol/L.
- Acute pulmonary embolism (segmental or more proximal) as the primary cause of hospitalization.
- Acute stroke.
- Chronic kidney disease stage 5 (estimated glomerular filtration rate < 15 ml/min/m²) or requirement for renal replacement therapy.
- Liver cirrhosis with portal hypertension.
- Known pulmonary disease with extensive parenchymal involvement, including interstitial lung disease, pulmonary metastases, prior pneumonectomy, lobectomy, or pleurodesis.
- Severe hypokalemia (serum potassium < 2.5 mmol/L).
- Pregnancy or breastfeeding.
- Refusal to participate in the clinical trial.
Where it is running
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Full record on ClinicalTrials.gov
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