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 chr

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.

journal_name

Am Heart J

journal_title

American heart journal

authors

Wiggers H,Køber L,Gislason G,Schou M,Poulsen MK,Vraa S,Nielsen OW,Bruun NE,Nørrelund H,Hollingdal M,Barasa A,Bøttcher M,Dodt K,Hansen VB,Nielsen G,Knudsen AS,Lomholdt J,Mikkelsen KV,Jonczy B,Brønnum-Schou J,Poenar

doi

10.1016/j.ahj.2020.09.020

subject

Has Abstract

pub_date

2021-01-01 00:00:00

pages

137-146

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(20)30276-3

journal_volume

231

pub_type

杂志文章,多中心研究,随机对照试验
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    更新日期:2011-07-01 00:00:00

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    更新日期:2008-02-01 00:00:00

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    更新日期:1997-08-01 00:00:00

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    更新日期:1992-03-01 00:00:00

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    更新日期:1988-02-01 00:00:00

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    pub_type: 临床试验,杂志文章,随机对照试验

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    更新日期:2004-01-01 00:00:00

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    journal_title:American heart journal

    pub_type: 杂志文章,多中心研究,随机对照试验

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    更新日期:2006-05-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1016/j.ahj.2011.03.011

    authors: Johansson P,Lesman-Leegte I,Svensson E,Voors A,van Veldhuisen DJ,Jaarsma T

    更新日期:2011-06-01 00:00:00

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    pub_type: 杂志文章

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    pub_type: 杂志文章

    doi:10.1016/0002-8703(78)90508-2

    authors: Silverman NH,Payot M,Stanger P

    更新日期:1978-06-01 00:00:00

  • Sequential changes in regional coronary flow during pacing-induced angina pectoris: coronary flow limitation precedes angina.

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    pub_type: 杂志文章

    doi:10.1016/0002-8703(84)90374-0

    authors: Wilson JR,Martin JL,Untereker WJ,Laskey W,Hirshfeld JW

    更新日期:1984-02-01 00:00:00

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    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(95)90009-8

    authors: Teien D,Jones M,Shiota T,Yamada I,Sahn DJ

    更新日期:1995-02-01 00:00:00

  • Lipid management in contemporary community practice: Results from the Provider Assessment of Lipid Management (PALM) Registry.

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    journal_title:American heart journal

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.ahj.2017.08.005

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    更新日期:2017-11-01 00:00:00

  • Effect of somatic nerve stimulation on coronary blood flow in anesthetized dogs.

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    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(79)90318-1

    authors: Kline RL

    更新日期:1979-07-01 00:00:00

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    journal_title:American heart journal

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1016/s0002-8703(97)70113-3

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    更新日期:1997-07-01 00:00:00

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    pub_type: 临床试验,杂志文章

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    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

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    更新日期:1999-02-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1016/j.ahj.2016.05.007

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    更新日期:2016-08-01 00:00:00

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    更新日期:2001-02-01 00:00:00

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    pub_type: 杂志文章,评审

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