1. The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART): A 2 x 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)☆
- Author
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Kiomars Mahboubi, Jens Brønnum-Schou, Jacob E. Møller, Jawdat Abdulla, Christian Torp-Petersen, Henrik Wiggers, Gitte Nielsen, Anders Hostrup Larsen, Karen Kaae Dodt, Anne Sejr Knudsen, Søren Lund Kristensen, Jens Lomholdt, Christian Hassager, Helene Nørrelund, Dan Eik Høfsten, Vibeke Brogaard Hansen, Søren Vraa, Hans Eiskjær, Søren Mellemkjær, Lars Køber, Malene Hollingdal, Ilan Raymond, O.W. Nielsen, Kristine Serup-Hansen, Jens Christian Refsgaard, Kirsten Vilain Mikkelsen, Anders Barasa, Niels Eske Bruun, Hans Erik Bøtker, Bo Martin Bibby, Finn Gustafsson, Morten Schou, Morten Bøttcher, Gunnar Gislason, Bartlomiej Jonczy, Jette Sandberg Madsen, Flemming Hald Steffensen, Monica Petronela Poenaru, Karen Sillesen, and Mikael Kjær Poulsen
- Subjects
Male ,medicine.medical_specialty ,Denmark ,Trial Designs ,Placebo-controlled study ,Myocardial Infarction ,030204 cardiovascular system & hematology ,Isosorbide Dinitrate ,Placebo ,GLUCOSE ,Placebos ,Prediabetic State ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,Diabetes mellitus ,Diabetes Mellitus ,EPIDEMIOLOGY ,Medicine ,Humans ,Hypoglycemic Agents ,030212 general & internal medicine ,Prediabetes ,Myocardial infarction ,Stroke ,Aged ,Heart Failure ,INSULIN-RESISTANCE ,OUTCOMES ,Ejection fraction ,business.industry ,MORTALITY ,Stroke Volume ,medicine.disease ,Hydralazine ,Metformin ,Hospitalization ,Drug Combinations ,VASODILATOR THERAPY ,Heart failure ,Chronic Disease ,Female ,FOLLOW-UP ,Cardiology and Cardiovascular Medicine ,business ,INTERVENTION ,LOW-RISK - 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.
- Published
- 2020