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The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART): A 2 × 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)

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  • Henrik Wiggers
  • Lars Køber
  • Gunnar Gislason
  • Morten Schou
  • Mikael Kjær Poulsen
  • Søren Vraa
  • Olav Wendelbo Nielsen
  • Niels Eske Bruun
  • Helene Nørrelund
  • Malene Hollingdal
  • Anders Barasa
  • Morten Bøttcher
  • Karen Dodt
  • Vibeke Brogaard Hansen
  • Gitte Nielsen
  • Anne Sejr Knudsen
  • Jens Lomholdt
  • Kirsten Vilain Mikkelsen
  • Bartlomiej Jonczy
  • Jens Brønnum-Schou
  • Monica Petronela Poenaru
  • Jawdat Abdulla
  • Ilan Raymond
  • Kiomars Mahboubi
  • Karen Sillesen
  • Kristine Serup-Hansen
  • Jette Sandberg Madsen
  • Søren Lund Kristensen
  • Anders Hostrup Larsen
  • Hans Erik Bøtker
  • Christian Torp-Petersen
  • Hans Eiskjær
  • Jacob Møller
  • Christian Hassager
  • Flemming Hald Steffensen
  • Bo Martin Bibby
  • Jens Refsgaard
  • Dan Eik Høfsten
  • Søren Mellemkjær
  • Finn Gustafsson
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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 × 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 2 commonly prescribed drugs with limited randomized data in patients with HFrEF.

Original languageEnglish
JournalAmerican Heart Journal
Pages (from-to)137-146
Number of pages10
Publication statusPublished - 1 Jan 2021

Bibliographical note

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