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 tidsskriftTidsskriftartikelForskningfagfællebedømt

Dokumenter

  • clep-12-1313

    Forlagets udgivne version, 442 KB, PDF-dokument

  • Henrik Wiggers
  • Mikael Kjær Poulsen
  • Søren Vraa
  • 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
  • Hans Eiskjær
  • Jacob Møller
  • Flemming Hald Steffensen
  • Bo Martin Bibby
  • Jens Refsgaard
  • Søren Mellemkjær

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

Bibliografisk note

Funding Information:
The DANHEART study has also received funding from the Novo Nordisk Foundation (0.48 million euro, grants no. NNF15OC0017450 and no. NNF18OC0052509), the Danish Health Regions Research Fund (0.33 million euro, grant no. 15/1716), the Independent Research Fund Denmark (0.34 million euro, grant no. DFF 6110-00263) and Aase and Ejnar Danielsens Foundation (0.027 million euro).

Funding Information:
This investigator driven study is financed through support from various foundations with The Danish Heart Foundation as the main contributor. The Danish Heart Foundation has guaranteed financial support up to an amount of 3.2 million Euro (grant no. 15-R100-A6113-93104). In addition to the direct study costs, the Danish Heart Foundation finances the cost of project managing during the study which is 0.44 million Euro.

Publisher Copyright:
© 2020 Elsevier Inc.

Antal downloads er baseret på statistik fra Google Scholar og www.ku.dk


Ingen data tilgængelig

ID: 285386080