Vanhentenrijk Simon, Verbeeck Johan, Kalpakos Theodoros, Vandoren Vincent, Braeckeveldt Laura, L'hoyes Wouter, Choustoulakis Eleftherios, Roosens Bram, Tang W H Wilson, Verwerft Jan, Verbrugge Frederik H
Centre for Cardiovascular Diseases, University Hospital Brussels, Jette, Belgium; Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.
Data Science Institute, Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-Biostat), University of Hasselt, Hasselt, Belgium.
J Card Fail. 2025 Apr;31(4):651-660. doi: 10.1016/j.cardfail.2024.08.044. Epub 2024 Aug 30.
To evaluate whether early-combination diuretic therapy guided by serial post-diuretic urine sodium concentration (UNa) assessments in acute heart failure (AHF) facilitates safe and effective decongestion.
The Diuretic Treatment in Acute Heart Failure with Volume Overload Guided by Serial Spot Urine Sodium Assessment (DECONGEST) study is a pragmatic, 2-center, randomized, parallel-arm, open-label study aiming to enroll 104 patients with AHF and clinically evident fluid overload requiring treatment with intravenous loop diuretics. Patients are randomized to receive standard of care or a bundled approach comprising: (1) systematic post-diuretic UNa assessments until successful decongestion, defined as no remaining clinical signs of fluid overload with a post-diuretic UNa ≤ 80 mmol/L; (2) thrice-daily intravenous loop diuretic bolus therapy, with dosing according to estimated glomerular filtration rate; (3) upfront use of intravenous acetazolamide (500 mg once daily [OD]); and (4) full nephron blockade with high-dose oral chlorthalidone (100 mg OD) and intravenous canreonate (200 mg OD) for diuretic resistance, defined as persisting signs of fluid overload with a post-diuretic UNa ≤ 80 mmol/L. The primary endpoint of the DECONGEST study is a hierarchical composite of (1) survival at 30 days; (2) days alive and out of hospital or care facility up to 30 days; and (3) greater relative decrease in natriuretic peptide levels from baseline to day 30.
The DECONGEST study aims to determine whether an intensive diuretic regimen focused on early combination therapy, guided by serial post-diuretic UNa+ assessments, safely enhances decongestion, warranting further evaluation in a larger trial powered for clinical events.
评估在急性心力衰竭（AHF）中，以系列利尿后尿钠浓度（UNa）评估为指导的早期联合利尿剂治疗是否有助于实现安全有效的消肿。
利尿后即时尿钠评估指导急性心力衰竭容量超负荷的利尿治疗（DECONGEST）研究是一项务实的、双中心、随机、平行组、开放标签研究，旨在纳入104例AHF且有临床明显液体超负荷需要静脉使用袢利尿剂治疗的患者。患者被随机分为接受标准治疗或综合治疗方案，该方案包括：（1）进行系统性利尿后UNa评估，直至成功消肿，成功消肿定义为无液体超负荷的临床体征且利尿后UNa≤80 mmol/L；（2）每日三次静脉注射袢利尿剂推注治疗，根据估算肾小球滤过率给药；（3）预先使用静脉注射乙酰唑胺（每日一次500 mg）；（4）对于利尿剂抵抗（定义为利尿后UNa≤80 mmol/L但仍有液体超负荷体征），使用高剂量口服氯噻酮（每日一次100 mg）和静脉注射坎利酸钾（每日一次200 mg）进行全肾单位阻断。DECONGEST研究的主要终点是一个分层复合终点，包括：（1）30天生存率；（2）至30天存活且未住院或未在护理机构的天数；（3）从基线到第30天利钠肽水平相对降低幅度更大。
DECONGEST研究旨在确定以系列利尿后UNa评估为指导、侧重于早期联合治疗的强化利尿方案是否能安全地增强消肿效果，这值得在一项针对临床事件有足够效力的更大规模试验中进一步评估。
