POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Study ID
- NCT07469722
- Phase
- PHASE2/PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Acute Heart Failure (AHF)
- Congestive Heart Failure Acute
- Diuretic Effect
- Lung Ultrasonography Score
- Point-of-care Ultrasound (POCUS)
- Ultrasonography, Doppler
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Furosemide 40 Milligrams. — DRUGDecongestive therapy with intravenous furosemide, with or without oral hydrochlorothiazide and/or oral acetazolamide, will be adjusted based on DUCS-based POCUS assessments. Procedure: DUCS-based POCUS protocol DUCS ranges from 0 to 10 points and is divided into three categories: absence of congestion (\<2 points), mild to moderate congestion (2-4 points) and severe congestion (≥5 points). DUCS integrates eight-zone lung ultrasound (each zone considered positive in the presence of ≥3 B-lines) and modified VExUS (inferior vena cava, portal vein and hepatic vein Doppler) assessments. For lung ultrasound, 2-3 positive zones score 2 points, 4-5 score 4 points and ≥6 score 5 points. For modified VExUS, grade 1 scores 1 point, grade 2 scores 2 points, and grade 3 scores 5 points. The final DUCS value is calculated as the sum of both components.
- Furosemide 40 Milligrams. — DRUGProcedure: physical examination according to the EVEREST congestion score and guideline-based treatment recommendations. Results from the physical examination will be provided to the medical team in the form of the EVEREST composite congestion score (CCS), which ranges from 0 to 9 and incorporates evaluation of jugular venous distension, pedal edema, and orthopnea. General guideline-based recommendations for the management of ADHF will be provided to the medical team.
- Hydrochlorothiazide (HCTZ) 25 milligrams. — DRUGAddition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum potassium and bicarbonate levels. Hydrochlorothiazide dose will be defined according to serum creatinine and estimated glomerular filtration rate (eGFR).
- Acetazolamide 250 milligrams. — DRUGAddition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum potassium, serum bicarbonate, and estimated glomerular filtration rate (eGFR).
- Dapagliflozin (10mg Tab) — DRUGDapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications.
- Potassium Chloride Oral Product — DRUGOral potassium chloride supplementation will be administered to patients with serum potassium \< 4.0 mEq/L in the experimental group.
Study Details
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 Dates
- Start date
- Mar 23, 2026
- Status verified
- Mar 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jul 1, 2028
Study Design
- Enrollment
- 128 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Standard of careStandard of care with additional information from the EVEREST congestion score and guideline-based treatment recommendations. Diuretics will be administered intravenously according to the institutional standard of care, with results from the EVEREST congestion score assessment and guideline-based treatment recommendations provided to the treating medical team. Dapagliflozin will also be suggested as part of guideline-directed medical therapy for patients without contraindications.
- Experimental: Diuretic therapy guided by DUCS-based POCUSTreatment recommendation will be made according to baseline DUCS-based POCUS assessment, as follows: Patients with DUCS 2-4 points (defined as mild to moderate congestion): the recommended intravenous loop diuretic dose will be twice the patient's previous total daily oral dose. If no diuretics were taken previously, intravenous furosemide 40 mg three times daily will be administered. Patients with DUCS ≥ 5 points (defined as severe congestion): the recommended intravenous loop diuretic dose will be twice the patient's previous total daily oral dose. If no diuretics were taken previously, intravenous furosemide 40 mg three times daily will be administered. Addition of a second diuretic will be recommended, either oral hydrochlorothiazide or oral acetazolamide, according to serum electrolyte levels. Serial DUCS-based POCUS assessments will provide recommendations for diuretic therapy adjustments. Dapagliflozin and oral potassium supplements will also be suggested if appropriate.
Primary Outcome Measure
Pairwise Comparisons With Wins of Clinical Benefit, a Composite of In-Hospital Mortality, Hospital Length of Stay, Absence of Congestion on DUCS at Discharge, and BNP Reduction From Admission to Day 7 or Discharge. [ Time Frame: From randomization until hospital discharge (assessed up to 90 days). ]
Central Contacts
- Henrique C Scherer, MD5551 33596246
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