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)

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Henrik Wiggers
  • Lars Køber, Rigshospitalet
  • ,
  • Gunnar Gislason, The Danish Heart Foundation
  • ,
  • Morten Schou, Herlev Hospital
  • ,
  • Mikael Kjær Poulsen, Odense University Hospital
  • ,
  • Søren Vraa, Aalborg Universitets Hospital, Danmark
  • Olav Wendelbo Nielsen, Bispebjerg Hospital
  • ,
  • Niels Eske Bruun, Roskilde Hospital
  • ,
  • Helene Nørrelund
  • Malene Hollingdal
  • Anders Barasa, Hvidovre Hospital, Hvidovre
  • ,
  • Morten Bøttcher
  • Karen Dodt
  • Vibeke Brogaard Hansen, Vejle Hospital
  • ,
  • Gitte Nielsen, Vendsyssel Hospital, Hjørring
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  • Anne Sejr Knudsen, Diagnostic Center, Silkeborg Hospital, Silkeborg, Denmark.
  • ,
  • Jens Lomholdt, Slagelse Hospital
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  • Kirsten Vilain Mikkelsen, Sydvestjysk Sygehus, Esbjerg
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  • Bartlomiej Jonczy, Sygehus Sønderjylland
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  • Jens Brønnum-Schou, Amager Hospital
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  • Monica Petronela Poenaru, Lillebaelt Hospital
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  • Jawdat Abdulla, Glostrup Hospital
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  • Ilan Raymond, Holbæk Hospital
  • ,
  • Kiomars Mahboubi, Randers Regional Hospital
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  • Karen Sillesen, Hospitalsapoteket Region Midtjylland
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  • Kristine Serup-Hansen, Department of Cardiology, Aarhus University Hospital, Denmark
  • ,
  • Jette Sandberg Madsen, Gentofte Hospital, Gentofte
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  • Søren Lund Kristensen, Rigshospitalet
  • ,
  • Anders Hostrup Larsen
  • ,
  • Hans Erik Bøtker
  • Christian Torp-Petersen, Hillerød Hospital
  • ,
  • Hans Eiskjær
  • Jacob Møller, Rigshospitalet
  • ,
  • Christian Hassager, Rigshospitalet
  • ,
  • Flemming Hald Steffensen, Hospital Lillebaelt
  • ,
  • Bo Martin Bibby
  • Jens Refsgaard
  • ,
  • Dan Eik Høfsten, Rigshospitalet
  • ,
  • Søren Mellemkjær
  • Finn Gustafsson, Rigshospitalet

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.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind231
Sider (fra-til)137-146
Antal sider10
ISSN0002-8703
DOI
StatusUdgivet - jan. 2021

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