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)
Copyright © 2020 Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:231 |
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| Enthalten in: |
American heart journal - 231(2021) vom: 10. Jan., Seite 137-146 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
26NAK24LS8 |
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| Anmerkungen: |
Date Completed 28.01.2021 Date Revised 25.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03514108 Citation Status MEDLINE |
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| doi: |
10.1016/j.ahj.2020.09.020 |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Wiggers, Henrik |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The DANish randomized, double-blind, placebo controlled trial in patients with chronic HEART failure (DANHEART) |b 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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| 500 | |a Date Completed 28.01.2021 | ||
| 500 | |a Date Revised 25.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03514108 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Elsevier Inc. All rights reserved. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a RESULTS: As of May 2020, 296 patients have been randomized at 20 centers in Denmark | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a Hydralazine |2 NLM | |
| 650 | 7 | |a 26NAK24LS8 |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 650 | 7 | |a Isosorbide Dinitrate |2 NLM | |
| 650 | 7 | |a IA7306519N |2 NLM | |
| 650 | 7 | |a isosorbide-hydralazine combination |2 NLM | |
| 650 | 7 | |a Metformin |2 NLM | |
| 650 | 7 | |a 9100L32L2N |2 NLM | |
| 650 | 7 | |a Placebos |2 NLM | |
| 700 | 1 | |a Køber, Lars |e verfasserin |4 aut | |
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| 700 | 1 | |a Schou, Morten |e verfasserin |4 aut | |
| 700 | 1 | |a Poulsen, Mikael Kjær |e verfasserin |4 aut | |
| 700 | 1 | |a Vraa, Søren |e verfasserin |4 aut | |
| 700 | 1 | |a Nielsen, Olav Wendelbo |e verfasserin |4 aut | |
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| 700 | 1 | |a Bøttcher, Morten |e verfasserin |4 aut | |
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| 700 | 1 | |a Hansen, Vibeke Brogaard |e verfasserin |4 aut | |
| 700 | 1 | |a Nielsen, Gitte |e verfasserin |4 aut | |
| 700 | 1 | |a Knudsen, Anne Sejr |e verfasserin |4 aut | |
| 700 | 1 | |a Lomholdt, Jens |e verfasserin |4 aut | |
| 700 | 1 | |a Mikkelsen, Kirsten Vilain |e verfasserin |4 aut | |
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| 700 | 1 | |a Abdulla, Jawdat |e verfasserin |4 aut | |
| 700 | 1 | |a Raymond, Ilan |e verfasserin |4 aut | |
| 700 | 1 | |a Mahboubi, Kiomars |e verfasserin |4 aut | |
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| 700 | 1 | |a Larsen, Anders Hostrup |e verfasserin |4 aut | |
| 700 | 1 | |a Bøtker, Hans Erik |e verfasserin |4 aut | |
| 700 | 1 | |a Torp-Petersen, Christian |e verfasserin |4 aut | |
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