Evidence map›Paper›PMID 31736342›Full record

ArticleCirculation2020

Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure.

Scott D Solomon, Muthiah Vaduganathan, Brian L Claggett, Milton Packer, Michael Zile, Karl Swedberg, Jean Rouleau, Marc A Pfeffer, Akshay Desai, Lars H Lund and 15 more

3 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 242 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
242citing papers in PubMed, 6 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.

NCT01035255 phase3terminatednot on this map

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2014Enrolled8,442ConditionsHeart Failure With Reduced Ejection FractionArmsLCZ696 200 mg BID, Enalapril 10 mg BID
NCT01920711 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2019Enrolled4,822ConditionsHeart Failure With Preserved Ejection FractionArmsLCZ696, Valsartan
NCT06995586 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

The Synergistic Action of Vitamins and Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.

TypeinterventionalSponsorNicosia General HospitalRan2026 to 2028Enrolled108ConditionsCardio-pulmonary Bypass, Cardiovascular Diseases, Omega-3 Polyunsaturated Fatty Acids, Omega-3 SupplementationArmsVitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose
3 · Its place in the literature

Who cites it

242 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).
Muthiah VaduganathanCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).
Brian L ClaggettCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).
Milton PackerBaylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).
Michael ZileMedical University of South Carolina, Charleston (M.Z.).
Karl SwedbergDepartment of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).
Jean RouleauInstitut de Cardiologie de Montréal, Université de Montréal, Canada (J.R.).
Marc A PfefferCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).
Akshay DesaiCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).
Lars H LundDepartment of Medicine, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden (L.H.L.).
Lars KoberDepartment of Cardiology, Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (L.K.).
Inder AnandDepartment of Medicine, VA Medical Center and University of Minnesota, Minneapolis (I.A.).
Nancy SweitzerSarver Heart Center, University of Arizona College of Medicine, Tucson (N.S.).
Gerard LinssenDepartment of Cardiology, Hospital Group Twente, Almelo and Hengelo, The Netherlands (G.L.).
Bela MerkelyHeart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).
Juan Luis ArangoGuatemalan Heart Institute (J.L.A.).
Dragos VinereanuUniversity of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).
Chen-Huan ChenDepartment of Medicine, National Yang-Ming University, Taipei, Taiwan, Republic of China (C.-H.C.).
Michele SenniCardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy (M.S.).
Antonio SibuloSt Luke's Heart Institute, St. Luke's Medical Center, Taguig, Philippines (A.S.).
Sergey BoytsovNational Research Center for Cardiology of the Ministry of Health of the Russian Federation, Moscow (S.B.).
Victor ShiNovartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).
Adel RizkalaNovartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).
Martin LefkowitzNovartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).
John J V McMurrayBritish Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile disease-modifying therapies exist for heart failure (HF) with reduced left ventricular ejection fraction (LVEF), few options are available for patients in the higher range of LVEF (>40%). Sacubitril/valsartan has been compared with a renin-angiotensin-aldosterone-system inhibitor alone in 2 similarly designed clinical trials of patients with reduced and preserved LVEF, permitting examination of its effects across the full spectrum of LVEF.

methodsWe combined data from PARADIGM-HF (LVEF eligibility≤40%; n=8399) and PARAGON-HF (LVEF eligibility≥45%; n=4796) in a prespecified pooled analysis. We divided randomized patients into LVEF categories: ≤22.5% (n=1269), >22.5% to 32.5% (n=3987), >32.5% to 42.5% (n=3143), > 42.5% to 52.5% (n=1427), > 52.5% to 62.5% (n=2166), and >62.5% (n=1202). We assessed time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality, and noncardiovascular mortality. Incidence rates and treatment effects were examined across categories of LVEF.

resultsAmong 13 195 randomized patients, we observed lower rates of cardiovascular death and HF hospitalization, but similar rates of noncardiovascular death, among patients in the highest versus the lowest groups. Overall sacubitril/valsartan was superior to renin-angiotensin-aldosterone-system inhibition for first cardiovascular death or heart failure hospitalization (Hazard Ratio [HR] 0.84 [95% CI, 0.78-0.90]), cardiovascular death (HR 0.84 [95% CI, 0.76-0.92]), heart failure hospitalization (HR 0.84 [95% CI, 0.77-0.91]), and all-cause mortality (HR 0.88 [95% CI, 0.81-0.96]). The effect of sacubitril/valsartan was modified by LVEF (treatment-by-continuous LVEF interaction

conclusionsThe therapeutic effects of sacubitril/valsartan, compared with a renin-angiotensin-aldosterone-system inhibitor alone, vary by LVEF with treatment benefits, particularly for heart failure hospitalization, that appear to extend to patients with heart failure and mildly reduced ejection fraction. These therapeutic benefits appeared to extend to a higher LVEF range in women compared with men. CLINICAL

trial registrationhttps://www.clinicaltrials.gov. Unique identifiers: NCT01920711 (PARAGON-HF), NCT01035255 (PARADIGM-HF).

Indexed as

AgedAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsFemaleHeart FailureHumansMaleMiddle AgedStroke VolumeTetrazolesTreatment OutcomeValsartanVentricular Function, LeftAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug Combinationssacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartanclinical efficacyheart failuresacubitril/valsartanventricular ejection fraction

Identifiers

PMID31736342

What OpenQuestion holds

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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.