Point-of-care Ultrasound Intervention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Furosemide 40 Milligrams. (Drug)
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.
干预措施: Furosemide 40 Milligrams. (Drug)
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.
干预措施: Hydrochlorothiazide (HCTZ) 25 milligrams. (Drug)
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.
干预措施: Acetazolamide 250 milligrams. (Drug)
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.
干预措施: Dapagliflozin (10mg Tab) (Drug)
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.
干预措施: Dapagliflozin (10mg Tab) (Drug)
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.
干预措施: Potassium Chloride Oral Product (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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).)
- Change in dyspnea assessed by the Visual Analogue Scale (VAS).(Up to day 5.)
- Proportion of participants with worsening renal function.(Up to day 7.)
- Proportion of patients without congestion on EVEREST at discharge.(From randomization until hospital discharge (assessed up to 90 days).)
- In-hospital mortality and major in-hospital clinical events.(From randomization until hospital discharge (assessed up to 90 days).)
- All-cause mortality or rehospitalization within 30 days.(From hospital discharge up to 30 days.)
- All-cause mortality or rehospitalization within 90 days.(From hospital discharge up to 90 days.)
- Proportion of participants with electrolyte abnormalities(From randomization until hospital discharge (assessed up to 90 days).)