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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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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. / 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). I: American Heart Journal. 2021 ; Bind 231. s. 137-146.

Bibtex

@article{4a231adf50754ea8b6ad5982e4458962,
title = "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)",
abstract = "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.",
author = "Henrik Wiggers and Lars K{\o}ber and Gunnar Gislason and Morten Schou and Poulsen, {Mikael Kj{\ae}r} and S{\o}ren Vraa and Nielsen, {Olav Wendelbo} and Bruun, {Niels Eske} and Helene N{\o}rrelund and Malene Hollingdal and Anders Barasa and Morten B{\o}ttcher and Karen Dodt and Hansen, {Vibeke Brogaard} and Gitte Nielsen and Knudsen, {Anne Sejr} and Jens Lomholdt and Mikkelsen, {Kirsten Vilain} and Bartlomiej Jonczy and Jens Br{\o}nnum-Schou and Poenaru, {Monica Petronela} and Jawdat Abdulla and Ilan Raymond and Kiomars Mahboubi and Karen Sillesen and Kristine Serup-Hansen and Madsen, {Jette Sandberg} and Kristensen, {S{\o}ren Lund} and Larsen, {Anders Hostrup} and B{\o}tker, {Hans Erik} and Christian Torp-Petersen and Hans Eiskj{\ae}r and Jacob M{\o}ller and Christian Hassager and Steffensen, {Flemming Hald} and Bibby, {Bo Martin} and Jens Refsgaard and H{\o}fsten, {Dan Eik} and S{\o}ren Mellemkj{\ae}r and Finn Gustafsson",
note = "Copyright {\textcopyright} 2020 Elsevier Inc. All rights reserved.",
year = "2021",
month = jan,
day = "1",
doi = "10.1016/j.ahj.2020.09.020",
language = "English",
volume = "231",
pages = "137--146",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby, Inc",

}

RIS

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 - Copyright © 2020 Elsevier Inc. All rights reserved.

PY - 2021/1/1

Y1 - 2021/1/1

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.

UR - http://www.scopus.com/inward/record.url?scp=85096379411&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2020.09.020

DO - 10.1016/j.ahj.2020.09.020

M3 - Journal article

C2 - 33039340

VL - 231

SP - 137

EP - 146

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -

ID: 61009432