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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)
Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review
Links
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544566/pdf/main.pdf
Forlagets udgivne version
DOI
- https://doi.org/10.1016/j.ahj.2020.09.020
Forlagets udgivne version
- https://doi.org/10.1016/j.ahj.2020.09.020
Forlagets udgivne version
- Henrik Wiggers
- Lars Køber, Københavns Universitet ,
- Gunnar Gislason, Hjerteforeningen ,
- Morten Schou, Københavns Universitet ,
- Mikael Kjær Poulsen, Syddansk Universitet ,
- Søren Vraa, Aalborg Universitet, Danmark
- Olav Wendelbo Nielsen, Region Hovedstaden ,
- Niels Eske Bruun, Roskilde Hospital ,
- Helene Nørrelund
- Malene Hollingdal
- Anders Barasa, Københavns Universitet ,
- Morten Bøttcher
- Karen Dodt
- Vibeke Brogaard Hansen, Syddansk Universitet ,
- Gitte Nielsen, Sygehus Vendsyssel ,
- Anne Sejr Knudsen
- Jens Lomholdt, Københavns Universitet ,
- Kirsten Vilain Mikkelsen, Sydvestjysk Sygehus ,
- Bartlomiej Jonczy, Region Syddanmark ,
- Jens Brønnum-Schou, Amager og Hvidovre Hospital ,
- Monica Petronela Poenaru, Syddansk Universitet ,
- Jawdat Abdulla, Rigshospitalet ,
- Ilan Raymond, Københavns Universitet ,
- Kiomars Mahboubi ,
- Karen Sillesen, Hospitalsapoteket Region Midtjylland ,
- Kristine Serup-Hansen ,
- Jette Sandberg Madsen, Region Hovedstaden ,
- Søren Lund Kristensen, Københavns Universitet ,
- Anders Hostrup Larsen
- Hans Erik Bøtker
- Christian Torp-Petersen, Nordsjællands Hospital ,
- Hans Eiskjær ,
- Jacob Møller, Københavns Universitet ,
- Christian Hassager, Københavns Universitet ,
- Flemming Hald Steffensen, Syddansk Universitet ,
- Bo Martin Bibby
- Jens Refsgaard
- Dan Eik Høfsten, Københavns Universitet ,
- Søren Mellemkjær
- Finn Gustafsson, Københavns Universitet
- Institut for Klinisk Medicin - Hjertesygdomme
- Dekanatet, Health
- Institut for Klinisk Medicin - Hjertesygdomme, Viborg
- Institut for Klinisk Medicin - Universitetsklinik for diagnostik, behandling og rehabilitering af iskæmisk hjertesygdom
- Institut for Klinisk Medicin - Medicinsk afdeling, Horsens
- Institut for Klinisk Medicin - Diagnostisk Center, Universitetsklinik for Innovative Patientforløb, Silkeborg
- Institut for Klinisk Medicin - Regionshospitalet Randers
- Institut for Folkesundhed - Biostatistik
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | American Heart Journal |
| Vol/bind | 231 |
| Sider (fra-til) | 137-146 |
| Antal sider | 10 |
| ISSN | 0002-8703 |
| DOI | |
| Status | Udgivet - jan. 2021 |
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