Journal Article

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)

Bøtker, Hans Erik, Dodt, Karen, Poenaru, Monica Petronela, Wiggers, Henrik, Knudsen, Anne Sejr, Hassager, Christian, Sillesen, Karen, Høfsten, Dan Eik, Lomholdt, Jens, Bruun, Niels Eske, Hollingdal, Malene, Bibby, Bo Martin, Schou, Morten, Mellemkjær, Søren, Gustafsson, Finn, Jonczy, Bartlomiej, Kristensen, Søren Lund, Køber, Lars, Bøttcher, Morten, Madsen, Jette Sandberg, Mikkelsen, Kirsten Vilain, Nielsen, Olav Wendelbo, Abdulla, Jawdat, Nørrelund, Helene, Hansen, Vibeke Brogaard, Eiskjær, Hans, Refsgaard, Jens, Serup-Hansen, Kristine, Gislason, Gunnar, Steffensen, Flemming Hald, Møller, Jacob, Barasa, Anders, Raymond, Ilan, Poulsen, Mikael Kjær, Brønnum-Schou, Jens, Mahboubi, Kiomars, Torp-Petersen, Christian, Nielsen, Gitte, Vraa, Søren, Larsen, Anders Hostrup

2021

Overview

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). 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. As of May 2020, 296 patients have been randomized at 20 centers in Denmark. 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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Aged / Antidiabetics / Blood pressure / Cardiovascular disease / Cerebral infarction / Chronic Disease / Congestive heart failure / Contraindications / Denmark / Diabetes / Diabetes mellitus / Diabetes Mellitus - drug therapy / Diabetes Mellitus - mortality / Double-Blind Method / Double-blind studies / Drug Combinations / Drug dosages / Factorial design / Female / Glucose / Heart failure / Heart Failure - drug therapy / Heart Failure - mortality / Hospitalization / Humans / Hydralazine - therapeutic use / Hypoglycemic Agents - therapeutic use / Hypotension / Insulin resistance / ISDN / Isosorbide Dinitrate - therapeutic use / Male / Metformin / Metformin - therapeutic use / Mortality / Multicenter Studies as Topic / Myocardial infarction / Myocardial Infarction - prevention & control / Patients / Placebos - therapeutic use / Prediabetic State - drug therapy / Prediabetic State - mortality / Randomized Controlled Trials as Topic / Stroke - prevention & control / Stroke Volume / Trial Designs