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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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). / 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.
I: American Heart Journal, Bind 231, 01.2021, s. 137-146.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART)
T2 - 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)
AU - Wiggers, Henrik
AU - Køber, Lars
AU - Gislason, Gunnar
AU - Schou, Morten
AU - Poulsen, Mikael Kjær
AU - Vraa, Søren
AU - Nielsen, Olav Wendelbo
AU - Bruun, Niels Eske
AU - Nørrelund, Helene
AU - Hollingdal, Malene
AU - Barasa, Anders
AU - Bøttcher, Morten
AU - Dodt, Karen
AU - Hansen, Vibeke Brogaard
AU - Nielsen, Gitte
AU - Knudsen, Anne Sejr
AU - Lomholdt, Jens
AU - Mikkelsen, Kirsten Vilain
AU - Jonczy, Bartlomiej
AU - Brønnum-Schou, Jens
AU - Poenaru, Monica Petronela
AU - Abdulla, Jawdat
AU - Raymond, Ilan
AU - Mahboubi, Kiomars
AU - Sillesen, Karen
AU - Serup-Hansen, Kristine
AU - Madsen, Jette Sandberg
AU - Kristensen, Søren Lund
AU - Larsen, Anders Hostrup
AU - Bøtker, Hans Erik
AU - Torp-Petersen, Christian
AU - Eiskjær, Hans
AU - Møller, Jacob
AU - Hassager, Christian
AU - Steffensen, Flemming Hald
AU - Bibby, Bo Martin
AU - Refsgaard, Jens
AU - Høfsten, Dan Eik
AU - Mellemkjær, Søren
AU - Gustafsson, Finn
N1 - Publisher Copyright: © 2020 Elsevier Inc.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
U2 - 10.1016/j.ahj.2020.09.020
DO - 10.1016/j.ahj.2020.09.020
M3 - Journal article
C2 - 33039340
AN - SCOPUS:85096379411
VL - 231
SP - 137
EP - 146
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -
ID: 285386080