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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).


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.

SUBMITTER: Wiggers H 

PROVIDER: S-EPMC7544566 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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 H   Køber Lars L   Gislason Gunnar G   Schou Morten M   Poulsen Mikael Kjær MK   Vraa Søren S   Nielsen Olav Wendelbo OW   Bruun Niels Eske NE   Nørrelund Helene H   Hollingdal Malene M   Barasa Anders A   Bøttcher Morten M   Dodt Karen K   Hansen Vibeke Brogaard VB   Nielsen Gitte G   Knudsen Anne Sejr AS   Lomholdt Jens J   Mikkelsen Kirsten Vilain KV   Jonczy Bartlomiej B   Brønnum-Schou Jens J   Poenaru Monica Petronela MP   Abdulla Jawdat J   Raymond Ilan I   Mahboubi Kiomars K   Sillesen Karen K   Serup-Hansen Kristine K   Madsen Jette Sandberg JS   Kristensen Søren Lund SL   Larsen Anders Hostrup AH   Bøtker Hans Erik HE   Torp-Petersen Christian C   Eiskjær Hans H   Møller Jacob J   Hassager Christian C   Steffensen Flemming Hald FH   Bibby Bo Martin BM   Refsgaard Jens J   Høfsten Dan Eik DE   Mellemkjær Søren S   Gustafsson Finn F  

American heart journal 20201009


<h4>Objectives</h4>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, wor  ...[more]

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