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)

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

doi:10.1016/j.ahj.2020.09.020

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)

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-SchouMonica 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^*

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

20 Citations (Scopus)

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.

Original language	English
Journal	American Heart Journal
Volume	231
Pages (from-to)	137-146
Number of pages	10
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2020.09.020
Publication status	Published - Jan 2021

Access to Document

10.1016/j.ahj.2020.09.020

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544566/pdf/main.pdf

AUB Link

Search for the material in Aalborg University Library's search engine

Fingerprint

Dive into the research topics of '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)'. Together they form a unique fingerprint.

Cite this

Wiggers, H., Køber, L., Gislason, G., Schou, M., Poulsen, M. K., Vraa, S., Nielsen, O. W., Bruun, N. E., Nørrelund, H., Hollingdal, M., Barasa, A., Bøttcher, M., Dodt, K., Hansen, V. B., Nielsen, G., Knudsen, A. S., Lomholdt, J., Mikkelsen, K. V., Jonczy, B., ... Gustafsson, F. (2021). 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). American Heart Journal, 231, 137-146. https://doi.org/10.1016/j.ahj.2020.09.020

Wiggers, Henrik ; Køber, Lars ; Gislason, Gunnar et al. / 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). In: American Heart Journal. 2021 ; Vol. 231. pp. 137-146.

@article{4f50278a26ba46099d4e5af45abb50fe,

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",

year = "2021",

month = jan,

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.",

}

Wiggers, H, Køber, L, Gislason, G, Schou, M, Poulsen, MK, Vraa, S, Nielsen, OW, Bruun, NE, Nørrelund, H, Hollingdal, M, Barasa, A, Bøttcher, M, Dodt, K, Hansen, VB, Nielsen, G, Knudsen, AS, Lomholdt, J, Mikkelsen, KV, Jonczy, B, Brønnum-Schou, J, Poenaru, MP, Abdulla, J, Raymond, I, Mahboubi, K, Sillesen, K, Serup-Hansen, K, Madsen, JS, Kristensen, SL, Larsen, AH, Bøtker, HE, Torp-Petersen, C, Eiskjær, H, Møller, J, Hassager, C, Steffensen, FH, Bibby, BM, Refsgaard, J, Høfsten, DE, Mellemkjær, S & Gustafsson, F 2021, '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)', American Heart Journal, vol. 231, pp. 137-146. https://doi.org/10.1016/j.ahj.2020.09.020

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 et al.
In: American Heart Journal, Vol. 231, 01.2021, p. 137-146.

Research output: Contribution to journal › Journal article › Research › peer-review

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

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.

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

SN - 0002-8703

VL - 231

SP - 137

EP - 146

JO - American Heart Journal

JF - American Heart Journal

ER -

Wiggers H, Køber L, Gislason G, Schou M, Poulsen MK, Vraa S et al. 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). American Heart Journal. 2021 Jan;231:137-146. Epub 2020 Oct 9. doi: 10.1016/j.ahj.2020.09.020

Abstract

Access to Document

AUB Link

Other files and links

Fingerprint

Cite this