Evidence map›Paper›PMID 31069575›Full record

ArticleCardiovascular drugs and therapy2019

Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.

Gavin A Lewis, Erik B Schelbert, Josephine H Naish, Emma Bedson, Susanna Dodd, Helen Eccleson, Dannii Clayton, Beatriz Duran Jimenez, Theresa McDonagh, Simon G Williams and 8 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Cardiovascular drugs and therapy, 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 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
7.6field-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.

NCT02932566 phase2completednot on this map

A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (PIROUETTE)

TypeinterventionalSponsorManchester University NHS Foundation TrustRan2017 to 2020Enrolled129ConditionsCardiac FailureArmsPirfenidone, Placebo
NCT05531955 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

A Study of Pirfenidone in the Treatment of Myocardial Fibrosis After Acute Myocardial Infarction: a Phase II Prospective, Randomized, Double-blind,Placebo Controlled Clinical Trial

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2024Enrolled100ConditionsMyocardial FibrosisArmsPirfenidone Oral Capsule, Placebo Oral Capsule
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 61 citations in OpenAlex.

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  20. Research Progress of Myocardial Fibrosis and Atrial Fibrillation.Frontiers in cardiovascular medicine · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 10 institutions in 2 countries.

Gavin A LewisDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Erik B SchelbertDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Josephine H NaishDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Emma BedsonClinical Trials Research Centre, 2nd Floor - Institute in the Park, Alder Hey Children's NHS Foundation Trust, University of Liverpool, Member of Liverpool Health Partners, Liverpool, L12 2AP, UK.
Susanna DoddDepartment of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
Helen EcclesonClinical Trials Research Centre, 2nd Floor - Institute in the Park, Alder Hey Children's NHS Foundation Trust, University of Liverpool, Member of Liverpool Health Partners, Liverpool, L12 2AP, UK.
Dannii ClaytonClinical Trials Research Centre, 2nd Floor - Institute in the Park, Alder Hey Children's NHS Foundation Trust, University of Liverpool, Member of Liverpool Health Partners, Liverpool, L12 2AP, UK.
Beatriz Duran JimenezManchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.
Theresa McDonaghKing's College Hospital, Denmark Hill, London, SE5 9RS, UK.
Simon G WilliamsManchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.
Anne CooperSalford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.
Colin CunningtonDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Fozia Zahir AhmedDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Rajavarma ViswesvaraiahStockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE, UK.
Stuart RussellEast Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL, UK.
Stefan NeubauerDivision of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Paula R WilliamsonDepartment of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
Christopher A MillerDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK. Christopher.Miller@manchester.ac.uk.
University of Liverpool · GBUniversity of Manchester · GBManchester Academic Health Science Centre · GBManchester University NHS Foundation Trust · GBEast Cheshire NHS Trust · GBKing's College Hospital · GBSalford Royal NHS Foundation Trust · GBStepping Hill Hospital · GBUniversity of Oxford · GBUniversity of Pittsburgh · US

Funding

Academy of Medical Sciences AMS-SGCL12-MILLERBritish Heart Foundation FS/17/47/32805Department of Health CS-2015-15-003EPA EP-C-15-003
6 · The paper itself

Abstract

backgroundThe PIROUETTE (PIRfenidOne in patients with heart failUre and preserved lEfT venTricular Ejection fraction) trial is designed to evaluate the efficacy and safety of the anti-fibrotic pirfenidone in patients with chronic heart failure and preserved ejection fraction (HFpEF) and myocardial fibrosis. HFpEF is a diverse syndrome associated with substantial morbidity and mortality. Myocardial fibrosis is a key pathophysiological mechanism of HFpEF and myocardial fibrotic burden is strongly and independently associated with adverse outcome. Pirfenidone is an oral anti-fibrotic agent, without haemodynamic effect, that leads to regression of myocardial fibrosis in preclinical models. It has proven clinical effectiveness in pulmonary fibrosis.

methodsThe PIROUETTE trial is a randomised, double-blind, placebo-controlled phase II trial evaluating the efficacy and safety of 52 weeks of treatment with pirfenidone in patients with chronic HFpEF (symptoms and signs of heart failure, left ventricular ejection fraction ≥ 45%, elevated natriuretic peptides [BNP ≥ 100 pg/ml or NT-proBNP ≥ 300 pg/ml; or BNP ≥ 300 pg/ml or NT-proBNP ≥ 900 pg/ml if in atrial fibrillation]) and myocardial fibrosis (extracellular matrix (ECM) volume ≥ 27% measured using cardiovascular magnetic resonance). The primary outcome measure is change in myocardial ECM volume. A sub-study will investigate the relationship between myocardial fibrosis and myocardial energetics, and the impact of pirfenidone, using DISCUSSION: PIROUETTE will determine whether pirfenidone is superior to placebo in relation to regression of myocardial fibrosis and improvement in myocardial energetics in patients with HFpEF and myocardial fibrosis (NCT02932566). CLINICAL

trial registrationclinicaltrials.gov (NCT02932566) https://clinicaltrials.gov/ct2/show/NCT02932566.

Indexed as

AdultAgedDouble-Blind MethodFemaleFibrosisHeart FailureHumansMaleMiddle AgedNatriuretic Peptide, BrainPeptide FragmentsPyridonesStroke VolumeVentricular Function, LeftNatriuretic Peptide, BrainPeptide Fragmentspirfenidonepro-brain natriuretic peptide (1-76)PyridonesFibrosisHeart failureMagnetic resonance imaging (MRI)

Identifiers

PMID31069575
PMCPMC6689029
OpenAlexW2944405399

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.