Evidence mapPaperPMID 33039340Full record

ArticleAmerican heart journal2021

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).

Henrik Wiggers, Lars Køber, Gunnar Gislason, Morten Schou, Mikael Kjær Poulsen, Søren Vraa, Olav Wendelbo Nielsen, Niels Eske Bruun, Helene Nørrelund, Malene Hollingdal and 30 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in American heart journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.1field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
  2. Review
  3. Advances in the Insulin-Heart Axis: Current Therapies and Future Directions.International journal of molecular sciences · 2024
    Review
  4. Characterization of the mFrontiers in immunology · 2024
    Article
  5. Review
  6. Repurposing Metformin for Vascular Disease.Current medicinal chemistry · 2023
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

40 authors at 20 institutions in 1 country.

Henrik WiggersDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: henrikwiggers@dadlnet.dk.
Lars KøberDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Gunnar GislasonThe Danish Heart Foundation, Copenhagen, Denmark.
Morten SchouDepartment of Cardiology, Herlev Hospital, Denmark.
Mikael Kjær PoulsenDepartment of Cardiology, Odense University Hospital, Denmark.
Søren VraaDepartment of Cardiology, Aalborg University Hospital, Denmark.
Olav Wendelbo NielsenDepartment of Cardiology, Bispebjerg Hospital, Denmark.
Niels Eske BruunDepartment of Cardiology, Roskilde Hospital, Denmark.
Helene NørrelundClinical Trial Unit, Aarhus University Hospital, Denmark.
Malene HollingdalDepartment of Cardiology, Viborg Hospital, Denmark.
Anders BarasaDepartment of Cardiology, Hvidovre Hospital, Denmark.
Morten BøttcherDepartment of Cardiology, Herning Hospital, Denmark.
Karen DodtDepartment of Cardiology, Horsens Hospital, Denmark.
Vibeke Brogaard HansenDepartment of Cardiology, Lillebaelt Hospital, Vejle Hospital, Denmark.
Gitte NielsenDepartment of Cardiology, Hjørring Hospital, Denmark.
Anne Sejr KnudsenDepartment of Cardiology, Silkeborg Hospital, Denmark.
Jens LomholdtDepartment of Cardiology, Slagelse Hospital, Denmark.
Kirsten Vilain MikkelsenDepartment of Cardiology, Sydvestjysk Sygehus, Esbjerg, Denmark.
Bartlomiej JonczyDepartment of Cardiology, Sygehus Sønderjylland, Abenraa, Denmark.
Jens Brønnum-SchouAmager Hospital, Denmark.
Monica Petronela PoenaruDepartment of Cardiology, Lillebaelt Hospital, Kolding, Denmark.
Jawdat AbdullaDepartment of Medicine, Cardiology Section, Glostrup Hospital, Denmark.
Ilan RaymondDepartment of Cardiology, Holbæk Hospital, Holbæk, Denmark.
Kiomars MahboubiDepartment of Cardiology, Randers Hospital, Randers, Denmark.
Karen SillesenThe Pharmacy, Aarhus University Hospital, Denmark.
Kristine Serup-HansenDepartment of Cardiology, Aarhus University Hospital, Denmark.
Jette Sandberg MadsenDepartment of Cardiology, Gentofte Hospital, Denmark.
Søren Lund KristensenDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Anders Hostrup LarsenDepartment of Cardiology, Aarhus University Hospital, Denmark.
Hans Erik BøtkerDepartment of Cardiology, Aarhus University Hospital, Denmark.
Christian Torp-PetersenDepartment of Cardiology, Hillerød Hospital, Denmark.
Hans EiskjærDepartment of Cardiology, Aarhus University Hospital, Denmark.
Jacob MøllerDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Christian HassagerDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Flemming Hald SteffensenDepartment of Cardiology, Lillebaelt Hospital, Vejle, Denmark.
Bo Martin BibbyDepartment of Biostatistics, Aarhus University, Aarhus, Denmark.
Jens RefsgaardDepartment of Cardiology, Viborg Hospital, Denmark.
Dan Eik HøfstenDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Søren MellemkjærDepartment of Cardiology, Aarhus University Hospital, Denmark.
Finn GustafssonDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark. Electronic address: Finn.Gustafsson@regionh.dk.
Aarhus University Hospital · DKRigshospitalet · DKLillebaelt Hospital · DKRegional Hospital Horsens · DKRegionshospitalet Viborg · DKVejle Sygehus · DKAalborg University Hospital · DKAarhus University · DKAmager Hospital · DKBispebjerg Hospital · DKFerring Pharmaceuticals (Denmark) · DKGentofte Hospital · DKGlostrup Hospital · DKHerlev Hospital · DKHolbæk Sygehus · DKHospital South West Jutland · DKHvidovre Hospital · DKOdense University Hospital · DKRegional Hospital Randers · DKRegionshospitalet Herning · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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).

methodsSymptomatic, 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.

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

conclusionThe 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.

Indexed as

Heart FailureHydralazineHypoglycemic AgentsIsosorbide DinitrateMetforminAgedChronic DiseaseDenmarkDiabetes MellitusDouble-Blind MethodDrug CombinationsFemaleHospitalizationHumansMaleMulticenter Studies as TopicDrug CombinationsHydralazineHypoglycemic AgentsIsosorbide Dinitrateisosorbide-hydralazine combinationMetforminPlacebos

Identifiers

PMID33039340
PMCPMC7544566
OpenAlexW3092141906

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.