Evidence map›Paper›PMID 31736335›Full record

Trial reportCirculation2020

Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial.

Mikhail N Kosiborod, Pardeep S Jhund, Kieran F Docherty, Mirta Diez, Mark C Petrie, Subodh Verma, Jose C Nicolau, Béla Merkely, Masafumi Kitakaze, David L DeMets and 12 more

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

Trial report in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT03036124. Cited by 158 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
158citing papers in PubMed, 9 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.

NCT03036124 phase3completed

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Ran2017Enrolled4,744Registered outcomes6Posted comparisons6ConditionsChronic Heart Failure With Reduced Ejection Fraction (HFrEF)Armsdapagliflozin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

158 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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98 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Mikhail N KosiborodSaint Luke's Mid America Heart Institute, University of Missouri-Kansas City (M.N.K.).
Pardeep S JhundBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
Kieran F DochertyBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
Mirta DiezDivision of Cardiology, Instituto Cardiovascular de Buenos Aires, Argentina (M.D.).
Mark C PetrieBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).
Subodh VermaSt Michael's Hospital, University of Toronto, Canada (S.V.).
Jose C NicolauInstituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, Brazil (J.C.N.).
Béla MerkelyHeart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).
Masafumi KitakazeDepartment of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita Osaka, Japan (M.K.).
David L DeMetsDepartment of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).
Silvio E InzucchiSection of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.).
Lars KøberRigshospitalet, Department of Cardiology, University of Copenhagen, Denmark (L.K.).
Felipe A MartinezUniversidad Nacional de Córdoba, Argentina (F.A.M.).
Piotr PonikowskiCenter for Heart Diseases, University Hospital, Wroclaw Medical University, Poland (P.P.).
Marc S SabatineDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.S.).
Scott D SolomonDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (M.S.S., S.D.S.).
Olof BengtssonLate Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
Daniel LindholmLate Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
Anna NiklassonLate Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
Mikaela SjöstrandLate Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
Anna Maria LangkildeLate Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (O.B., D.L., A.N., M.S., A.M.L.).
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, UK (P.S.J., K.F.D., M.C.P., J.J.V.M.).

Funding

Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Kevan C Herold, GERALD I SHULMAN · 1993 to 2026
$44.0M
British Heart Foundation RE/18/6/34217NIDDK NIH HHS P30 DK045735
6 · The paper itself

Abstract

backgroundGoals of management in patients with heart failure and reduced ejection fraction include reducing death and hospitalizations, and improving health status (symptoms, physical function, and quality of life). In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), sodium-glucose cotransporter-2 inhibitor, dapagliflozin, reduced death and hospitalizations, and improved symptoms in patients with heart failure and reduced ejection fraction. In this analysis, we examine the effects of dapagliflozin on a broad range of health status outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

methodsKCCQ was evaluated at randomization, 4 and 8 months. Patients were divided by baseline KCCQ total symptom score (TSS); Cox proportional hazards models examined the effects of dapagliflozin on clinical events across these subgroups. We also evaluated the effects of dapagliflozin on KCCQ-TSS, clinical summary score, and overall summary score. Responder analyses were performed to compare proportions of dapagliflozin versus placebo-treated patients with clinically meaningful changes in KCCQ at 8 months.

resultsA total of 4443 patients had available KCCQ at baseline (median KCCQ-TSS, 77.1 [interquartile range, 58.3-91.7]). The effects of dapagliflozin vs placebo on reducing cardiovascular death or worsening heart failure were consistent across the range of KCCQ-TSS (lowest to highest tertile: hazard ratio, 0.70 [95% CI, 0.57-0.86]; hazard ratio, 0.77 [95% CI, 0.61-0.98]; hazard ratio, 0.62 [95% CI, 0.46-0.83];

conclusionsDapagliflozin reduced cardiovascular death and worsening heart failure across the range of baseline KCCQ, and improved symptoms, physical function, and quality of life in patients with heart failure and reduced ejection fraction. Furthermore, dapagliflozin increased the proportion of patients experiencing at least small, moderate, and large improvements in health status; these effects were clinically important. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT03036124.

Indexed as

Quality of LifeVentricular Function, LeftAgedBenzhydryl CompoundsFemaleGlucosidesHeart FailureHospitalizationHumansMaleMiddle AgedOdds RatioPlacebo EffectProportional Hazards ModelsProspective StudiesSurvival AnalysisBenzhydryl CompoundsdapagliflozinGlucosideshealth statusheart failureoutcomesodium-glucose transporter 2 inhibitors

Identifiers

PMID31736335
PMCPMC6964869

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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.