POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure

Official title

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

Overview

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.

Interventions

• 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) a
• 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.

Primary outcome measures

• 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).]

Secondary outcome measures (12)

• All-cause in-hospital mortality. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• Hospital length of stay. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• Proportion of patients without congestion on POCUS at discharge. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• BNP reduction. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• Change in body weight. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• Change in dyspnea assessed by the Visual Analogue Scale (VAS). [Time frame: Up to day 5.]
• Proportion of participants with worsening renal function. [Time frame: Up to day 7.]
• Proportion of patients without congestion on EVEREST at discharge. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• In-hospital mortality and major in-hospital clinical events. [Time frame: From randomization until hospital discharge (assessed up to 90 days).]
• All-cause mortality or rehospitalization within 30 days. [Time frame: From hospital discharge up to 30 days.]
• All-cause mortality or rehospitalization within 90 days. [Time frame: From hospital discharge up to 90 days.]
• Proportion of participants with electrolyte abnormalities [Time frame: From randomization until hospital discharge (assessed up to 90 days).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Hospital de Clínicas de Porto Alegre — Porto Alegre

Publications

• Metra M, Adamo M, Tomasoni D, Mebazaa A, Bayes-Genis A, Abdelhamid M, Adamopoulos S, Anker SD, Bauersachs J, Belenkov Y, Bohm M, Gal TB, Butler J, Cohen-Solal A, Filippatos G, Gustafsson F, Hill L, Jaarsma T, Jankowska EA, Lainscak M, Lopatin Y, Lund LH, McDonagh T, Milicic D, Moura B, Mullens W, Piepoli M, Polovina M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Thum T, PMID 37448210
• 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).

Identifiers

NCT: NCT07469722 · 2025-0708

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗