Acute Heart Failure (AHF), Congestive Heart Failure Acute, Diuretic Effect, Lung Ultrasonography Score, Ultrasonography, Doppler, Point-of-care Ultrasound (POCUS)
Conditions
Keywords
Acute Heart Failure, Congestive Heart Failure, Point-of-Care Ultrasound, Lung Ultrasound, Venous Excess Ultrasound, Diuretic
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.
Interventions
DRUGFurosemide 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.
DRUGHydrochlorothiazide (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).
DRUGAcetazolamide 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).
Dapagliflozin will be suggested to the treating medical team as part of guideline-directed medical therapy for patients without contraindications.
Oral potassium chloride supplementation will be administered to patients with serum potassium \< 4.0 mEq/L in the experimental group.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From randomization until hospital discharge (assessed up to 90 days). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause in-hospital mortality. | From randomization until hospital discharge (assessed up to 90 days). | All-cause mortality occurring between hospital admission and discharge will be analyzed to compare the treatment groups. |
| Proportion of patients without congestion on POCUS at discharge. | From randomization until hospital discharge (assessed up to 90 days). | 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. |
| BNP reduction. | From randomization until hospital discharge (assessed up to 90 days). | 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. |
| Change in body weight. | From randomization until hospital discharge (assessed up to 90 days). | Change in body weight, measured in kilograms, between hospital admission and discharge will be compared between treatment groups. |
| Change in dyspnea assessed by the Visual Analogue Scale (VAS). | Up to day 5. | 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. |
| Proportion of participants with worsening renal function. | Up to day 7. | 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. |
| Proportion of patients without congestion on EVEREST at discharge. | From randomization until hospital discharge (assessed up to 90 days). | The proportion of patients with EVEREST composite congestion score (CCS) ≤ 2 points at hospital discharge will be compared between treatment groups. |
| In-hospital mortality and major in-hospital clinical events. | From randomization until hospital discharge (assessed up to 90 days). | 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. |
| All-cause mortality or rehospitalization within 30 days. | From hospital discharge up to 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. |
| All-cause mortality or rehospitalization within 90 days. | From hospital discharge up to 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. |
| Hospital length of stay. | From randomization until hospital discharge (assessed up to 90 days). | Hospital length of stay, measured in days, will be compared between treatment groups. |
| Proportion of participants with electrolyte abnormalities | From randomization until hospital discharge (assessed up to 90 days). | 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). |
Countries
Brazil
Contacts
CONTACTHenrique C Scherer, MD
STUDY_CHAIRLuis E Rohde, Professor
Hospital de Clínicas de Porto Alegre
Outcome results
None listed