Rationale and Design of the DECONGEST (Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment) Study.

AIMS: 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. METHODS: 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. CONCLUSION: 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.

FFRct use for acute chest pain triage in the emergency department: a cost-effectiveness analysis.

AIMS: To model and assess the cost-effectiveness of CT-based fractional flow reserve (FFRct) for a population of low to intermediate risk patients for coronary artery disease (CAD) presenting to the emergency department (ED) with acute chest pain. METHODS AND RESULTS: Using a decision tree model with a 1 year time horizon and from a health care perspective, two diagnostic pathways using FFRct are compared to current clinical routine combining coronary computed tomography angiography (CCTA) with an exercise test. Model data are drawn from the literature and nationally reported data. Outcomes are assessed as the number of avoided invasive coronary angiographies (ICAs) showing no obstructive CAD and quality of life (QoL) in a theoretical cohort of 1000 patients. Sensitivity analyses are performed to test the robustness of the results. Determining FFRct when CCTA is inconclusive is a cost-effective and dominant strategy with a potential saving of 198€/patient, 154 avoided unnecessary ICA showing no obstructive CAD (uICA)/1000 patients and an average improvement in QoL of 0.008 QALY/patient. With an additional 574€/patient, 8 avoided uICA/1000 patients and an improvement in QoL of 0.001 QALY/patient, a strategy where FFRct is always performed is cost-effective only when considering high cost-effectiveness thresholds. CONCLUSIONS: For patients presenting to the ED with acute chest pain and a low to intermediate pre-test probability of CAD, a diagnostic strategy where FFRct is determined after an inconclusive CCTA is cost-effective. Clinical trials investigating both sensitivity and specificity of FFRct, as well as QoL associated with the use of this technology in this setting are warranted.