RESUMO
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.
Assuntos
Insuficiência Cardíaca/tratamento farmacológico , Hidralazina/uso terapêutico , Hipoglicemiantes/uso terapêutico , Dinitrato de Isossorbida/uso terapêutico , Metformina/uso terapêutico , Idoso , Doença Crônica , Dinamarca , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/mortalidade , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Insuficiência Cardíaca/mortalidade , Hospitalização , Humanos , Masculino , Infarto do Miocárdio/prevenção & controle , Placebos/uso terapêutico , Estado Pré-Diabético/tratamento farmacológico , Estado Pré-Diabético/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Volume SistólicoRESUMO
Overall, the future emergency departments in Denmark serve as a single portal of entry for all acute patients. At the same time an expansion of prehospital diagnosing and triage will take place. In patients suspected of life-threatening cardiac conditions with specialized treatment requirements where the time factor is important, the prehospital triage will be important to identify patients who should be transferred directly to a cardiac care unit to reduce prehospital and in-hospital delays of treatment.
