Ontology highlight
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
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]