Evidence map›Paper›PMID 36522606›Full record

Trial reportNature medicine2022

Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial.

Orly Vardeny, James C Fang, Akshay S Desai, Pardeep S Jhund, Brian Claggett, Muthiah Vaduganathan, Rudolf A de Boer, Adrian F Hernandez, Carolyn S P Lam, Silvio E Inzucchi and 14 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT03619213. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT03619213 phase3completed

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

Ran2018Enrolled6,263Registered outcomes7Posted comparisons7ConditionsHeart Failure With Preserved Ejection FractionArmsdapagliflozin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Orly VardenyMinneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota, Minneapolis, MN, USA. ovardeny@umn.edu.ORCID http://orcid.org/0000-0002-6387-1351
James C FangUniversity of Utah Medical Center, Salt Lake City, UT, USA.
Akshay S DesaiCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Pardeep S JhundBHF Glasgow Cardiovascular Research Center, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0003-4306-5317
Brian ClaggettCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Muthiah VaduganathanCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Rudolf A de BoerDepartment of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.ORCID http://orcid.org/0000-0002-4775-9140
Adrian F HernandezDuke University Medical Center, Durham, NC, USA.
Carolyn S P LamNational Heart Centre Singapore and Duke-National University of Singapore, Singapore, Singapore.ORCID http://orcid.org/0000-0003-1903-0018
Silvio E InzucchiYale School of Medicine, New Haven, CT, USA.
Felipe A MartinezUniversidad Nacional de Córdoba, Córdoba, Argentina.
Mikhail N KosiborodSaint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.ORCID http://orcid.org/0000-0002-3750-9789
David DeMetsUniversity of Wisconsin, Madison, WI, USA.
Eileen O'MearaMontreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.
Shelley ZierothSt. Boniface Hospital & University of Manitoba, Winnipeg, Manitoba, Canada.ORCID http://orcid.org/0000-0002-6145-9814
Josep Comin-ColetCardiology Department, Bellvitge University Hospital, Bio-Heart Bellvitge Institute for Biomedical Research, University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain.ORCID http://orcid.org/0000-0001-8780-720X
Jaroslaw DrozdzDepartment Cardiology, Medical University Lodz, Lodz, Poland.ORCID http://orcid.org/0000-0002-0732-2104
Chern-En ChiangGeneral Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan.
Masafumi KitakazeKinshukai Hanwa Daini Senboku Hospital, Osaka, Japan.ORCID http://orcid.org/0000-0001-5157-4213
Magnus PeterssonLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID http://orcid.org/0000-0002-4099-0710
Daniel LindholmLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.ORCID http://orcid.org/0000-0003-3526-0614
Anna Maria LangkildeLate-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
John J V McMurrayBHF Glasgow Cardiovascular Research Center, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-6317-3975
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. ssolomon@bwh.harvard.edu.ORCID http://orcid.org/0000-0003-3698-9597

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With modern treatments for heart failure with reduced ejection fraction (EF), indicative of impaired cardiac systolic function, patients may exhibit an increase in EF. Limited data are available regarding the clinical management of this growing population, categorized as heart failure with improved EF (HFimpEF), which has a high event rate and has been excluded from virtually all prior heart failure outcomes trials. In a prespecified analysis of the DELIVER trial ( NCT03619213 ), of a total of 6,263 participants with symptomatic heart failure and a left ventricular EF >40%, 1,151 (18%) had HFimpEF, defined as patients whose EF improved from ≤40% to >40%. Participants were randomized to 10 mg dapagliflozin or placebo daily and the primary outcome of the trial was a composite of cardiovascular death or worsening heart failure (heart failure hospitalization or an urgent heart failure visit). Participants with HFimpEF had similar event rates to those with an EF consistently >40%. In participants with HFimpEF, dapagliflozin reduced the primary composite outcome (hazard ratio (HR) = 0.74, 95% confidence interval (CI) = 0.56-0.97), first worsening heart failure events (HR = 0.78, 95% CI = 0.61-1.14), cardiovascular death (HR = 0.62, 95% CI = 0.41-0.96) and total worsening heart failure events (rate ratio = 0.68, 95% CI = 0.50-0.94) to a similar extent as for individuals with an EF consistently >40%. These data suggest that patients with HFimpEF who are symptomatic may benefit from the addition of a sodium/glucose cotransporter 2 inhibitor to previously instituted guideline-directed medical therapy to further reduce morbidity and mortality.

Indexed as

Heart FailureBenzhydryl CompoundsGlucosidesHumansVentricular Function, LeftBenzhydryl CompoundsdapagliflozinGlucosides

Identifiers

PMID36522606
PMCPMC9800271

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Registered trials

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 OpenQuestion graph.