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- W2546924501 abstract "Background: The oral vasopressin-2 receptor antagonist tolvaptan causes aquaresis in patients with volume overload, which could potentially facilitate decongestion and improve the clinical course of patients with acute heart failure (AHF). Objectives: To address the role of the acute use of tolvaptan to improve symptoms of congestion in AHF, we conducted the Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure Study (TACTICS-HF, NCT01644331). Methods: TACTICS-HF randomized patients within 24 hours of presentation with AHF and volume overload in a prospective, double blind, placebo-controlled trial. Patients were eligible regardless of ejection fraction. Eligible patients were randomized to either 30 mg of tolvaptan or placebo given at 0, 24, and 48 hours, with a fixed dose furosemide regimen as background therapy. The primary endpoint was the proportion of patients with at least moderate improvement in dyspnea by 7-point Likert scale at both 8 and 24 hours and without the need for rescue therapy or death within 24 hours. Secondary endpoints included symptom improvement, changes in renal function, and clinical events. Results: A total of 257 patients were randomized. Dyspnea relief by Likert scale was similar between tolvaptan and placebo at 8 hours (25% moderately or markedly improved for tolvaptan vs. 28% for placebo, P = .59) and at 24 hours (50% moderately or markedly improved for tolvaptan vs. 47% for placebo, P = .80) (Fig. 1). Need for rescue therapy was also similar at 24 hours (21% for tolvaptan, 18% for placebo, P = .57). The proportion of patients defined as responders at 24 hours (the primary study endpoint) was 16% in tolvaptan and 20% in placebo (P = .32). Tolvaptan did result in greater weight loss and net fluid loss, as well as trends towards improved dyspnea relief, less worsening heart failure, and a greater proportion of patients classified as responders at 48 and 72 hours. Tolvaptan treated patients were more likely to experience worsening renal function during treatment, although changes in renal function were generally modest. There were no differences in in-hospital or post-discharge clinical outcomes. Conclusions: In patients hospitalized with AHF, dyspnea, and congestion, the addition of tolvaptan to a standardized furosemide regimen improved weight loss and fluid loss but did not improve the proportion of patients classified as responders at 24 hours." @default.
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- W2546924501 date "2016-11-01" @default.
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- W2546924501 title "The Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure Study: A Randomized, Double blind, Placebo-Controlled Trial in Acute Heart Failure" @default.
- W2546924501 doi "https://doi.org/10.1016/j.cardfail.2016.09.010" @default.
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