POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure

NCT07469722 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-0708
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Heart Failure (AHF); Congestive Heart Failure Acute; Diuretic Effect; Lung Ultrasonography Score; Ultrasonography, Doppler; Point-of-care Ultrasound (POCUS)

Keywords

Acute Heart Failure; Congestive Heart Failure; Point-of-Care Ultrasound; Lung Ultrasound; Venous Excess Ultrasound; Diuretic

Outcome Measures

Primary Outcomes (1)

• 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.

  Clinical benefit will be assessed using a hierarchical composite endpoint based on pairwise comparisons (win ratio analysis), including the following components, analyzed in a predefined hierarchical order: 1. In-hospital mortality: death is worse than no death; earlier death is worse than later death; tied if not possible to determine. 2. Hospital length of stay (days): a shorter hospital length of stay is better; a difference of ≥1 day defines a win; tied if the same number of length of stay days. 3. Absence of congestion on DUCS at discharge: \<2 points at discharge on DUCS is better; tied if both have ≥2 points or if both have \<2 points on DUCS. 4. BNP reduction at day 7 or discharge (whichever occurs first): a reduction of ≥30% in BNP is better; tied if both achieve or do not achieve a ≥30% reduction.

  From randomization until hospital discharge (assessed up to 90 days).

Secondary Outcomes (12)

• All-cause in-hospital mortality.

  From randomization until hospital discharge (assessed up to 90 days).

• Hospital length of stay.

  From randomization until hospital discharge (assessed up to 90 days).

• Proportion of patients without congestion on POCUS at discharge.

  From randomization until hospital discharge (assessed up to 90 days).

• BNP reduction.

  From randomization until hospital discharge (assessed up to 90 days).

• Change in body weight.

  From randomization until hospital discharge (assessed up to 90 days).

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Standard 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.

Drug: Furosemide 40 Milligrams.; Drug: Dapagliflozin (10mg Tab)

Diuretic therapy guided by DUCS-based POCUS

EXPERIMENTAL

Treatment 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.

Drug: Furosemide 40 Milligrams.; Drug: Hydrochlorothiazide (HCTZ) 25 milligrams.; Drug: Acetazolamide 250 milligrams.; Drug: Dapagliflozin (10mg Tab); Drug: Potassium Chloride Oral Product

Interventions

Furosemide 40 Milligrams. DRUG

Decongestive 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.

Diuretic therapy guided by DUCS-based POCUS

Hydrochlorothiazide (HCTZ) 25 milligrams. DRUG

Addition 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).

Diuretic therapy guided by DUCS-based POCUS

Acetazolamide 250 milligrams. DRUG

Addition 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).

Diuretic therapy guided by DUCS-based POCUS

Dapagliflozin (10mg Tab) DRUG

Dapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications.

Diuretic therapy guided by DUCS-based POCUS; Standard of care

Potassium Chloride Oral Product DRUG

Oral potassium chloride supplementation will be administered to patients with serum potassium \< 4.0 mEq/L in the experimental group.

Diuretic therapy guided by DUCS-based POCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

Related Publications (2)

• 2. Metra M, Adamo M, Tomasoni D, et al. Pre-discharge and early post-discharge management of patients hospitalized for acute heart failure: a scientific statement by the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2023 Jul 13;25(7).

  BACKGROUND

• 1. Telo GH, Saadi MP, Silvano GP, Silveira AD da, Biolo A. Contribution of Lung Ultrasound and VExUS in the Diagnosis and Monitoring of Patients with Heart Failure. ABC Heart Fail Cardiomyop. 2024;4(1).

  BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Hydrochlorothiazide; dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luis E Rohde, Professor

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

Central Study Contacts

Henrique C Scherer, MD

CONTACT

5551 33596246; henriquecscherer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 13, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

BR (1)