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) - 18/12/20
Doi : 10.1016/j.ahj.2020.09.020
Henrik Wiggers, MD, PhD, DMSc a, ⁎, 1 
, Lars Køber, MD, PhD, DMSc b, Gunnar Gislason, MD, PhD, DMSc c, Morten Schou, MD, PhD, DMSc d, Mikael Kjær Poulsen, MD, PhD e, Søren Vraa, MD f, Olav Wendelbo Nielsen, MD, PhD, DMSc g, Niels Eske Bruun, MD, PhD, DMSc h, Helene Nørrelund, MD, PhD, DMSc i, Malene Hollingdal, MD, PhD j, Anders Barasa, MD, PhD k, Morten Bøttcher, MD, PhD l, Karen Dodt, MD, PhD m, Vibeke Brogaard Hansen, MD, PhD n, Gitte Nielsen, MD, PhD o, Anne Sejr Knudsen, MD p, Jens Lomholdt, MD q, Kirsten Vilain Mikkelsen, MD, PhD r, Bartlomiej Jonczy, MD s, Jens Brønnum-Schou, MD t, Monica Petronela Poenaru, MD u, Jawdat Abdulla, MD, PhD v, Ilan Raymond, MD, PhD w, Kiomars Mahboubi, MD x, Karen Sillesen, RPh y, Kristine Serup-Hansen, RN z, Jette Sandberg Madsen, RN aa, Søren Lund Kristensen, MD, PhD b, Anders Hostrup Larsen, MD, PhD z, Hans Erik Bøtker, MD, PhD, DMSc z, Christian Torp-Petersen, MD, DMSc ab, Hans Eiskjær, MD, DMSc z, Jacob Møller, MD, PhD, DMSc b, Christian Hassager, MD, DMSc b, Flemming Hald Steffensen, MD, PhD ac, Bo Martin Bibby, Stat, PhD ad, Jens Refsgaard, MD, PhD j, Dan Eik Høfsten, MD, PhD b, Søren Mellemkjær, MD, PhD z, Finn Gustafsson, MD, PhD, DMSc b, ⁎⁎, 2
, Lars Køber, MD, PhD, DMSc b, Gunnar Gislason, MD, PhD, DMSc c, Morten Schou, MD, PhD, DMSc d, Mikael Kjær Poulsen, MD, PhD e, Søren Vraa, MD f, Olav Wendelbo Nielsen, MD, PhD, DMSc g, Niels Eske Bruun, MD, PhD, DMSc h, Helene Nørrelund, MD, PhD, DMSc i, Malene Hollingdal, MD, PhD j, Anders Barasa, MD, PhD k, Morten Bøttcher, MD, PhD l, Karen Dodt, MD, PhD m, Vibeke Brogaard Hansen, MD, PhD n, Gitte Nielsen, MD, PhD o, Anne Sejr Knudsen, MD p, Jens Lomholdt, MD q, Kirsten Vilain Mikkelsen, MD, PhD r, Bartlomiej Jonczy, MD s, Jens Brønnum-Schou, MD t, Monica Petronela Poenaru, MD u, Jawdat Abdulla, MD, PhD v, Ilan Raymond, MD, PhD w, Kiomars Mahboubi, MD x, Karen Sillesen, RPh y, Kristine Serup-Hansen, RN z, Jette Sandberg Madsen, RN aa, Søren Lund Kristensen, MD, PhD b, Anders Hostrup Larsen, MD, PhD z, Hans Erik Bøtker, MD, PhD, DMSc z, Christian Torp-Petersen, MD, DMSc ab, Hans Eiskjær, MD, DMSc z, Jacob Møller, MD, PhD, DMSc b, Christian Hassager, MD, DMSc b, Flemming Hald Steffensen, MD, PhD ac, Bo Martin Bibby, Stat, PhD ad, Jens Refsgaard, MD, PhD j, Dan Eik Høfsten, MD, PhD b, Søren Mellemkjær, MD, PhD z, Finn Gustafsson, MD, PhD, DMSc b, ⁎⁎, 2 a Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
b Department of Cardiology, Rigshospitalet, Copenhagen, Denmark
c The Danish Heart Foundation, Copenhagen, Denmark
d Department of Cardiology, Herlev Hospital, Denmark
e Department of Cardiology, Odense University Hospital, Denmark
f Department of Cardiology, Aalborg University Hospital, Denmark
g Department of Cardiology, Bispebjerg Hospital, Denmark
h Department of Cardiology, Roskilde Hospital, Denmark
i Clinical Trial Unit, Aarhus University Hospital, Denmark
j Department of Cardiology, Viborg Hospital, Denmark
k Department of Cardiology, Hvidovre Hospital, Denmark
l Department of Cardiology, Herning Hospital, Denmark
m Department of Cardiology, Horsens Hospital, Denmark
n Department of Cardiology, Lillebaelt Hospital, Vejle Hospital, Denmark
o Department of Cardiology, Hjørring Hospital, Denmark
p Department of Cardiology, Silkeborg Hospital, Denmark
q Department of Cardiology, Slagelse Hospital, Denmark
r Department of Cardiology, Sydvestjysk Sygehus, Esbjerg, Denmark
s Department of Cardiology, Sygehus Sønderjylland, Abenraa, Denmark
t Amager Hospital, Denmark
u Department of Cardiology, Lillebaelt Hospital, Kolding, Denmark
v Department of Medicine, Cardiology Section, Glostrup Hospital, Denmark
w Department of Cardiology, Holbæk Hospital, Holbæk, Denmark
x Department of Cardiology, Randers Hospital, Randers, Denmark
y The Pharmacy, Aarhus University Hospital, Denmark
z Department of Cardiology, Aarhus University Hospital, Denmark
aa Department of Cardiology, Gentofte Hospital, Denmark
ab Department of Cardiology, Hillerød Hospital, Denmark
ac Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark
ad Department of Biostatistics, Aarhus University, Aarhus, Denmark
⁎Reprint requests: Professor Henrik Wiggers, MD, PhD, DMSc, Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard, Aarhus, Denmark.Department of CardiologyAarhus University HospitalPalle Juul-Jensens BoulevardAarhusDenmark⁎⁎Reprint requests: Professor Finn Gustafsson, MD, PhD, DMSc, Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.Department of CardiologyRigshospitaletCopenhagenDenmark
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.
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| Conflict of interest: None relevant (investigator-initiated, non-commercial study) |
|
| Declaration of interest: None relevant (investigator-initiated, non-commercial study) |
|
| Funding and support 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. 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). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents. |
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