Evidence map›Paper›PMID 37212758›Full record

Trial reportJournal of the American College of Cardiology2023

Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure.

Robert J Mentz, Jonathan H Ward, Adrian F Hernandez, Serge Lepage, David A Morrow, Samiha Sarwat, Kavita Sharma, Randall C Starling, Eric J Velazquez, Kristin M Williamson and 5 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03988634 (A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled Study to Evaluate the Effect of Sacubitril/Valsartan), which is not on this map. Cited by 76 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 5 pooled it
33.4field-weighted citation impact, top 1% 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.

NCT03988634 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2019 to 2022Enrolled467ConditionsHeart Failure With Preserved Ejection Fraction (HFpEF)Armssacubitril/valsartan, valsartan, sacubitril/valsartan matching placebo, valsartan matching placebo
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 5 syntheses or guidelines pooled it, 153 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 2 countries.

Robert J MentzDuke Clinical Research Institute, Durham, North Carolina, USA. Electronic address: robert.mentz@duke.edu.
Jonathan H WardNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Adrian F HernandezDuke Clinical Research Institute, Durham, North Carolina, USA.
Serge LepageDepartment of Cardiology, Université de Sherbrooke, Sherbrooke, Quebec, Canada.
David A MorrowCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Samiha SarwatNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Kavita SharmaDivision of Cardiology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Randall C StarlingDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
Eric J VelazquezDepartment of Internal Medicine, Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Kristin M WilliamsonNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Akshay S DesaiCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Shelley ZierothSection of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Scott D SolomonCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Eugene BraunwaldCardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
PARAGLIDE-HF Investigators
Brigham and Women's Hospital · USNovartis (United States) · USClinical Research Institute · USCleveland Clinic · USHarvard University · USJohns Hopkins University · USUniversité de Sherbrooke · CAUniversity of Manitoba · CAYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundU.S. guidelines recommend consideration of sacubitril/valsartan in chronic heart failure (HF) and mildly reduced or preserved ejection fraction (EF). Whether initiation is safe and effective in EF >40% after a worsening heart failure (WHF) event is unknown.

objectivesPARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) assessed sacubitril/valsartan vs valsartan in EF >40% following a recent WHF event.

methodsPARAGLIDE-HF is a double-blind, randomized controlled trial of sacubitril/valsartan vs valsartan in patients with EF >40% enrolled within 30 days of a WHF event. The primary endpoint was time-averaged proportional change in amino terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. A secondary hierarchical outcome (win ratio) consisted of: 1) cardiovascular death; 2) HF hospitalizations; 3) urgent HF visits; and 4) change in NT-proBNP.

resultsIn 466 patients (233 sacubitril/valsartan; 233 valsartan), time-averaged reduction in the NT-proBNP was greater with sacubitril/valsartan (ratio of change: 0.85; 95% CI: 0.73-0.999; P = 0.049). The hierarchical outcome favored sacubitril/valsartan but was not significant (unmatched win ratio: 1.19; 95% CI: 0.93-1.52; P = 0.16). Sacubitril/valsartan reduced worsening renal function (OR: 0.61; 95% CI: 0.40-0.93) but increased symptomatic hypotension (OR: 1.73; 95% CI: 1.09-2.76). There was evidence of a larger treatment effect in the subgroup with EF ≤60% for NT-proBNP change (0.78; 95% CI: 0.61-0.98) and the hierarchical outcome (win ratio: 1.46; 95% CI: 1.09-1.95).

conclusionsAmong patients with EF >40% stabilized after WHF, sacubitril/valsartan led to greater reduction in plasma NT-proBNP levels and was associated with clinical benefit compared with valsartan alone, despite more symptomatic hypotension. (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634).

Indexed as

Heart FailureHypotensionAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAngiotensinsBiphenyl CompoundsDrug CombinationsHumansNeprilysinStroke VolumeTetrazolesValsartanAminobutyratesAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAngiotensinsBiphenyl CompoundsDrug CombinationsNeprilysinsacubitrilTetrazolesValsartanacute decompensated HFpEFclinical outcomesHFmrEFnatriuretic peptidessacubitril/valsartan

Identifiers

PMID37212758
OpenAlexW4377193384

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.