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
Аннотация
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.