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

Hospital de Clinicas de Porto Alegre

Status and phase: Not yet enrolling; Phase 3; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07469722

2025-0708

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

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.

Treatment:

Drug: Furosemide 40 Milligrams.

Drug: Furosemide 40 Milligrams.

Drug: Dapagliflozin (10mg Tab)

Diuretic therapy guided by DUCS-based POCUS

Experimental group

Description:

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.

Treatment:

Drug: Hydrochlorothiazide (HCTZ) 25 milligrams.

Drug: Furosemide 40 Milligrams.

Drug: Furosemide 40 Milligrams.

Drug: Dapagliflozin (10mg Tab)

Drug: Acetazolamide 250 milligrams.

Drug: Potassium Chloride Oral Product