Evidence map›Paper›PMID 31806129›Full record

Trial reportJournal of the American College of Cardiology2019

Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction.

Amil M Shah, Maja Cikes, Narayana Prasad, Guichu Li, Stoyan Getchevski, Brian Claggett, Adel Rizkala, Ilya Lukashevich, Eileen O'Meara, John J Ryan and 7 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 133 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed, 4 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.

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
NCT05220891 unknown statusnot on this mapstarted 2023, after this paper: background citation

Comparison of Crystalloid and Colloid I.V Fluid Therapy in Prevention of Paracentesis Induced Circulatory Dysfunction (PICD) and Renal Dysfunction in Patients With Decompensated Liver Cirrhosis in Egypt: a Randomized Piolet Study

TypeobservationalSponsorShady Ashraf KassemRan2023 to 2024Enrolled60ConditionsAscitesArmsParacentesis
3 · Its place in the literature

Who cites it

133 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Amil M ShahDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ashah11@rics.bwh.harvard.edu.
Maja CikesUniversity of Zagreb School of Medicine and University Hospital Centre Zagreb, Department for Cardiovascular Diseases, Zagreb, Croatia.
Narayana PrasadDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Guichu LiDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Stoyan GetchevskiDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Brian ClaggettDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Adel RizkalaNovartis, East Hanover, New Jersey.
Ilya LukashevichNovartis, East Hanover, New Jersey.
Eileen O'MearaMontreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.
John J RyanUniversity of Utah, Salt Lake City, Utah.
Sanjiv J ShahNorthwestern University, Chicago, Illinois.
Wilfred MullensZiekenhuis Oost Limburg, Genk, Belgium.
Michael R ZileThe Medical University of South Carolina and the Ralph H. Johnson VA Medical Center, Charleston, South Carolina.
Carolyn S P LamNational Heart Centre Singapore and Duke-National University of Singapore, Singapore; University Medical Centre Groningen, Groningen, the Netherlands; The George Institute for Global Health, Newtown, New South Wales, Australia.
John J V McMurrayUniversity of Glasgow, Glasgow, United Kingdom.
Scott D SolomonDivision of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
PARAGON-HF Investigators

Funding

Mapping the Progression to HFpEF in the Elderly through Longitudinal Changes in Cardiac FunctionR01HL135008 · NHLBI · UT SOUTHWESTERN MEDICAL CENTER · PI Amil M Shah · 2017 to 2026
$11.5M
Transition from Risk Factors to Early HF: Prevalence, Pathogenesis, and PhenomicsR01HL127028 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BERTONI, ALAIN GERALD, SHAH, SANJIV J · 2015 to 2018
$6.5M
Study of Cardiac Mechanics in Systemic HypertensionR01HL107577 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SHAH, SANJIV J · 2011 to 2019
$4.1M
Quantifying cardiac structure and function to define the progression to hear failure in African AmericansR01HL143224 · NHLBI · UT SOUTHWESTERN MEDICAL CENTER · PI SHAH, AMIL M · 2018 to 2021
$3.4M
Machine learning for the automated identification and tracking of rare myocardial diseasesR01HL140731 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MACRAE, CALUM A., SHAH, SANJIV J · 2018 to 2021
$2.8M
Precision Medicine for Dilated Cardiomyopathy—Novel Assessment of Cardiac Mechanics via Speckle Tracking Echocardiography to Identify Early PhenotypesR01HL149423 · NHLBI · OHIO STATE UNIVERSITY · PI HERSHBERGER, RAY E., KINNAMON, DANIEL DAVIS · 2019 to 2022
$1.6M
Systolic & diastolic dysfunction in heart failure and preserved ejection fractionK08HL116792 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SHAH, AMIL M · 2013 to 2017
$735k
Mentoring patient-oriented research in deep phenotyping of cardiac function for heart failure preventionK24HL152008 · NHLBI · UT SOUTHWESTERN MEDICAL CENTER · PI SHAH, AMIL M · 2020 to 2024
$608k
NHLBI NIH HHS K08 HL116792NHLBI NIH HHS K24 HL152008NHLBI NIH HHS R01 HL107577NHLBI NIH HHS R01 HL127028NHLBI NIH HHS R01 HL135008NHLBI NIH HHS R01 HL140731NHLBI NIH HHS R01 HL143224NHLBI NIH HHS R01 HL149423
6 · The paper itself

Abstract

backgroundThe PARAGON-HF (Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction) trial tested the efficacy of sacubitril-valsartan in patients with heart failure with preserved ejection fraction (HFpEF). Existing data on cardiac structure and function in patients with HFpEF suggest significant heterogeneity.

objectivesThe aim of this study was to characterize cardiac structure and function, quantify their associations with clinical outcomes, and contextualize these findings with other HFpEF studies.

methodsEchocardiography was performed in 1,097 of 4,822 PARAGON-HF patients within 6 months of enrollment. Associations with incident first heart failure hospitalization or cardiovascular death were assessed using Cox proportional hazards models adjusted for age, sex, region of enrollment, randomized treatment, N-terminal pro-brain natriuretic peptide, and clinical risk factors.

resultsAverage age was 74 ± 8 years, 53% of patients were women, median N-terminal pro-brain natriuretic peptide level was 918 pg/ml (interquartile range: 485 to 1,578 pg/ml), 94% had hypertension, and 35% had atrial fibrillation. The mean left ventricular (LV) ejection fraction was 58.6 ± 9.8%, prevalence of LV hypertrophy was 21%, prevalence of left atrial enlargement was 83%, prevalence of elevated E/e' ratio was 53%, and prevalence of pulmonary hypertension was 31%. Heart failure hospitalization or cardiovascular death occurred in 288 patients at 2.8-year median follow-up. In fully adjusted models, higher LV mass index (hazard ratio [HR]: 1.05 per 10 g/m

conclusionsDiastolic dysfunction, left atrial enlargement, and pulmonary hypertension were common in PARAGON-HF. LV hypertrophy, elevated left- and right-sided pressures, and right ventricular enlargement were independently predictive of incident heart failure hospitalization or cardiovascular death. Echocardiographic differences among HFpEF trials despite similar clinical event rates highlight the heterogeneity of this syndrome. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).

Indexed as

AgedAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDiastoleDouble-Blind MethodDrug CombinationsEchocardiographyFemaleFollow-Up StudiesHeart FailureHeart VentriclesHumansMaleMiddle AgedNeprilysinAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug CombinationsNeprilysinsacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartandiastolic functionechocardiographyheart failurepreserved left ventricular function

Identifiers

PMID31806129
PMCPMC13537700

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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.