POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure (POINTER-HF)

Point-of-care Ultrasound Intervention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Heart Failure (AHF); Ultrasonography, Doppler; Point-of-care Ultrasound (POCUS); Lung Ultrasonography Score; Diuretic Effect; Congestive Heart Failure Acute
• Intervention / Treatment: Drug: Furosemide 40 Milligrams.; Drug: Furosemide 40 Milligrams.; Drug: Hydrochlorothiazide (HCTZ) 25 milligrams.; Drug: Acetazolamide 250 milligrams.; Drug: Dapagliflozin (10mg Tab); Drug: Potassium Chloride Oral Product

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Henrique C Scherer, MD; Phone Number: 5551 33596246; Email: henriquecscherer@gmail.com

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90410-000
      • Hospital de Clinicas de Porto Alegre
      • Contact: Henrique C Scherer, MD; Phone Number: 5551 33596246; Email: henriquecscherer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; 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.; 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.; Drug: Furosemide 40 Milligrams.; Procedure: 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.; Drug: Dapagliflozin (10mg Tab); Dapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications.
Experimental: Diuretic therapy guided by DUCS-based POCUS; 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.; 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.; Drug: Furosemide 40 Milligrams.; Procedure: 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.; Drug: Hydrochlorothiazide (HCTZ) 25 milligrams.; 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).; Drug: Acetazolamide 250 milligrams.; 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).; Drug: Dapagliflozin (10mg Tab); Dapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications.; Drug: Potassium Chloride Oral Product; Oral potassium chloride supplementation will be administered to patients with serum potassium < 4.0 mEq/L in the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: In-hospital mortality: death is worse than no death; earlier death is worse than later death; tied if not possible to determine.; 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.; 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.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause in-hospital mortality.	All-cause mortality occurring between hospital admission and discharge will be analyzed to compare the treatment groups.	From randomization until hospital discharge (assessed up to 90 days).
Hospital length of stay.	Hospital length of stay, measured in days, will be compared between treatment groups.	From randomization until hospital discharge (assessed up to 90 days).
Proportion of patients without congestion on POCUS at discharge.	Absence of residual congestion at hospital discharge, defined as DUCS <2 points, will be compared between the intervention group and the standard-of-care group.	From randomization until hospital discharge (assessed up to 90 days).
BNP reduction.	The proportion of patients achieving a ≥30% reduction in BNP from hospital admission to day 7 or hospital discharge (whichever occurs first) will be compared between the intervention and control groups.	From randomization until hospital discharge (assessed up to 90 days).
Change in body weight.	Change in body weight, measured in kilograms, between hospital admission and discharge will be compared between treatment groups.	From randomization until hospital discharge (assessed up to 90 days).
Change in dyspnea assessed by the Visual Analogue Scale (VAS).	The area under the curve (AUC) of change in VAS dyspnea score will be compared between treatment groups. Individual scores will be plotted over time, with the x-axis representing study days from baseline to day 5, and the y-axis representing the VAS score (0-100 millimeters). The VAS AUC (millimeter x hour) will be compared between treatment groups.	Up to day 5.
Proportion of participants with worsening renal function.	Worsening renal function will be defined as an increase of ≥0.3 mg/dL in serum creatinine or a ≥50% increase from baseline within 7 days.	Up to day 7.
Proportion of patients without congestion on EVEREST at discharge.	The proportion of patients with EVEREST composite congestion score (CCS) ≤ 2 points at hospital discharge will be compared between treatment groups.	From randomization until hospital discharge (assessed up to 90 days).
In-hospital mortality and major in-hospital clinical events.	A composite outcome including in-hospital mortality, admission to intensive care unit, use of mechanical ventilation, renal replacement therapy, vasopressor use, or inotrope use during the index hospitalization will be assessed and compared between treatment groups.	From randomization until hospital discharge (assessed up to 90 days).
All-cause mortality or rehospitalization within 30 days.	The proportion of participants who experience all-cause mortality or rehospitalization within 30 days after hospital discharge will be compared between treatment groups.	From hospital discharge up to 30 days.
All-cause mortality or rehospitalization within 90 days.	The proportion of participants who experience all-cause mortality or rehospitalization within 90 days after hospital discharge will be compared between treatment groups.	From hospital discharge up to 90 days.
Proportion of participants with electrolyte abnormalities	The proportion of participants with electrolyte abnormalities will be compared between treatment groups, including hypokalemia (serum potassium < 3.0 mEq/L), hyperkalemia (serum potassium > 5.5 mEq/L), hyponatremia (serum sodium < 125 mEq/L), hypernatremia (serum sodium > 150 mEq/L), hypomagnesemia (serum magnesium < 1.2 mg/dL), hypermagnesemia (serum magnesium > 3.0 mg/dL), and metabolic acidosis (serum bicarbonate < 14 mEq/L with arterial pH < 7.15).	From randomization until hospital discharge (assessed up to 90 days).

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Chair: Luis E Rohde, Professor, Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• 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).
• 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).

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Congestive Heart Failure; Diuretic; Acute Heart Failure; Point-of-Care Ultrasound; Lung Ultrasound; Venous Excess Ultrasound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Sulfones; Chlorothiazide; Benzothiadiazines; Thiazides; Hydrochlorothiazide; dapagliflozin
• Other Study ID Numbers: 2025-0708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No