Selected article for: "active treatment and acute heart failure"

Author: Wiggers, Henrik; Køber, Lars; Gislason, Gunnar; Schou, Morten; Poulsen, Mikael Kjær; Vraa, Søren; Nielsen, Olav Wendelbo; Bruun, Niels Eske; Nørrelund, Helene; Hollingdal, Malene; Barasa, Anders; Bøttcher, Morten; Dodt, Karen; Hansen, Vibeke Brogaard; Nielsen, Gitte; Knudsen, Anne Sejr; Lomholdt, Jens; Mikkelsen, Kirsten Vilain; Jonczy, Bartlomiej; Brønnum-Schou, Jens; Poenaru, Monica Petronela; Abdulla, Jawdat; Raymond, Ilan; Mahboubi, Kiomars; Sillesen, Karen; Serup-Hansen, Kristine; Madsen, Jette Sandberg; Kristensen, Søren Lund; Larsen, Anders Hostrup; Bøtker, Hans Erik; Torp-Petersen, Christian; Eiskjær, Hans; Møller, Jacob; Hassager, Christian; Steffensen, Flemming Hald; Bibby, Bo Martin; Refsgaard, Jens; Høfsten, Dan Eik; Mellemkjær, Søren; Gustafsson, Finn
Title: The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART): A 2 x 2 factorial trial of hydralazine-isosorbide dinitrate in patients with chronic heart failure (H-HeFT) and metformin in patients with chronic heart failure and diabetes or prediabetes (met-HeFT)()
  • Cord-id: z9ffmapz
  • Document date: 2020_10_9
  • ID: z9ffmapz
    Snippet: OBJECTIVES: The DANHEART trial is a multicenter, randomized (1:1), parallel-group, double-blind, placebo-controlled study in chronic heart failure patients with reduced ejection fraction (HFrEF). This investigator driven study will include 1500 HFrEF patients and test in a 2 x 2 factorial design: 1) if hydralazine-isosorbide dinitrate reduces the incidence of death and hospitalization with worsening heart failure vs. placebo (H-HeFT) and 2) if metformin reduces the incidence of death, worsening
    Document: OBJECTIVES: The DANHEART trial is a multicenter, randomized (1:1), parallel-group, double-blind, placebo-controlled study in chronic heart failure patients with reduced ejection fraction (HFrEF). This investigator driven study will include 1500 HFrEF patients and test in a 2 x 2 factorial design: 1) if hydralazine-isosorbide dinitrate reduces the incidence of death and hospitalization with worsening heart failure vs. placebo (H-HeFT) and 2) if metformin reduces the incidence of death, worsening heart failure, acute myocardial infarction, and stroke vs. placebo in patients with diabetes or prediabetes (Met-HeFT). METHODS: Symptomatic, optimally treated HFrEF patients with LVEF ≤40% are randomized to active vs. placebo treatment. Patients can be randomized in either both H-HeFT and Met-HeFT or to only one of these study arms. In this event-driven study, it is anticipated that 1300 patients should be included in H-HeFT and 1100 in Met-HeFT and followed for an average of 4 years. RESULTS: As of May 2020, 296 patients have been randomized at 20 centers in Denmark. CONCLUSION: The H-HeFT and Met-HeFT studies will yield new knowledge about the potential benefit and safety of two commonly prescribed drugs with limited randomized data in patients with HFrEF.

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