NCT07469722Not yet recruitingPhase 2/3
POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
Point-of-care Ultrasound Intervention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 3 Mar 2026
- Start date
- 23 Mar 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- Heart failure
- NCT number
- NCT07469722
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 128
- From 23 Mar 2026 to the primary completion date, 31 Jan 2028
- 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.
Prior treatment
- Patients under evaluation for heart transplantation or with prior heart transplantation.
- Cardiac surgery or percutaneous coronary or structural cardiac intervention within the previous 30 days.
- Known pulmonary disease with extensive parenchymal involvement, including interstitial lung disease, pulmonary metastases, prior pneumonectomy, lobectomy, or pleurodesis.
Other illness
- Acute coronary syndrome as the primary cause of hospitalization.
- Evidence of uncontrolled infection.
- 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.
Lab values
- 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.
- Severe hypokalemia (serum potassium \< 2.5 mmol/L).
Other
- Acute pulmonary embolism (segmental or more proximal) as the primary cause of hospitalization.
- Pregnancy or breastfeeding.
- Refusal to participate in the clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.