Evidence map›Paper›PMID 32192799›Full record

Trial reportJournal of the American College of Cardiology2020

Systolic Blood Pressure in Heart Failure With Preserved Ejection Fraction Treated With Sacubitril/Valsartan.

Senthil Selvaraj, Brian L Claggett, Michael Böhm, Stefan D Anker, Muthiah Vaduganathan, Faiez Zannad, Burkert Pieske, Carolyn S P Lam, Inder S Anand, Victor C Shi and 3 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01920711 (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), which is not on this map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% 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.

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
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 79 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 5 countries.

Senthil SelvarajDivision of Cardiology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: https://twitter.com/senthil_selv.
Brian L ClaggettDivision of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Michael BöhmDepartment of Internal Medicine and Cardiology, German Center for Cardiovascular Research partner site Berlin, Berlin, Germany; Klinik für Innere Medizin III, Universität des Saarlandes, Homburg, Germany.
Stefan D AnkerDepartment of Internal Medicine and Cardiology, German Center for Cardiovascular Research partner site Berlin, Berlin, Germany; Klinik für Innere Medizin III, Universität des Saarlandes, Homburg, Germany.
Muthiah VaduganathanDivision of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Faiez ZannadINSERM Centre d'Investigation Clinic 1433 and Universite de Lorraine, Centre Hospitalier Regional et Universitaire, Nancy, France.
Burkert PieskeDepartment of Internal Medicine and Cardiology, German Center for Cardiovascular Research partner site Berlin, Berlin, Germany.
Carolyn S P LamNational Heart Center Singapore and Duke-National University of Singapore, Singapore.
Inder S AnandDepartment of Cardiovascular Medicine, University of Minnesota, Minneapolis, Minnesota.
Victor C ShiNovartis, East Hanover, New Jersey.
Martin P LefkowitzNovartis, East Hanover, New Jersey.
John J V McMurrayBHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
Scott D SolomonDivision of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ssolomon@rics.bwhharvard.edu.
Brigham and Women's Hospital · USNovartis (United States) · USUniversitätsklinikum des Saarlandes · DEGerman Centre for Cardiovascular Research · DEInserm · FRNational University of Singapore · SGTwitter (United States) · USUniversity of Glasgow · GBUniversity of Minnesota · US

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
Training Program in Cardiovascular Biology and MedicineT32HL007843 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI THOMAS P. CAPPOLA, Sharlene M Day · 1996 to 2026
$11.0M
NCATS NIH HHS UL1 TR002541NHLBI NIH HHS T32 HL007843
6 · The paper itself

Abstract

backgroundGuidelines recommend targeting systolic blood pressure (SBP) <130 mm Hg in heart failure with preserved ejection fraction (HFpEF) with limited data.

objectivesThis study sought to determine the optimal achieved SBP and whether the treatment effects of sacubitril/valsartan on outcomes are related to BP lowering, particularly among women who derive greater benefit from sacubitril/valsartan.

methodsUsing 4,795 trial participants, this study related baseline and time-updated mean achieved SBP quartiles (<120, 120 to 129, 130 to 139, ≥140 mm Hg) to the primary outcome (cardiovascular death and total heart failure hospitalization), its components, myocardial infarction or stroke, and a renal composite outcome. At the 16-week visit, the study assessed the relationship between SBP change and Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) and N-terminal pro-B-type natriuretic peptide (NT-proBNP). The study analyzed whether the BP-lowering effects of sacubitril/valsartan accounted for its treatment effects.

resultsAverage age was 73 ± 8 years, and 52% of participants were women. After multivariable adjustment, baseline and mean achieved SBP of 120 to 129 mm Hg demonstrated the lowest risk for all outcomes. Sacubitril/valsartan reduced SBP by 5.2 mm Hg (95% confidence interval: 4.4 to 6.0) compared with valsartan at 4 weeks, which was not modified by baseline SBP. However, sacubitril/valsartan reduced SBP more in women (6.3 mm Hg) than men (4.0 mm Hg) (interaction p = 0.005). Change in SBP was directly associated with change in NT-proBNP (p < 0.001) but not KCCQ-OSS (p = 0.40). The association between sacubitril/valsartan and the primary outcome was not modified by baseline SBP (interaction p = 0.50) and was similar when adjusting for time-updated SBP, regardless of sex.

conclusionsBaseline and mean achieved SBP of 120 to 129 mm Hg identified the lowest risk patients with HFpEF. Baseline SBP did not modify the treatment effect of sacubitril/valsartan, and the BP-lowering effects of sacubitril/valsartan did not account for its effects on outcomes, regardless of sex. (Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).

Indexed as

AminobutyratesHeart FailureTetrazolesAgedAngiotensin Receptor AntagonistsBiphenyl CompoundsBlood PressureDouble-Blind MethodDrug CombinationsDrug MonitoringFemaleHumansMaleNatriuretic Peptide, BrainNeprilysinOutcome Assessment, Health CareAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsNatriuretic Peptide, BrainNeprilysinPeptide Fragmentspro-brain natriuretic peptide (1-76)sacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartanblood pressureheart failure hospitalizationheart failure with preserved ejection fractionsacubitril/valsartan

Identifiers

PMID32192799
PMCPMC8109279
OpenAlexW3012482957

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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.