PoplarV1, Main, Exploration, bibRecord, 000780

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

Identifieur interne : 000780 ( Main/Exploration ); précédent : 000779; suivant : 000781

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

Auteurs : Gavin A. Lewis [Royaume-Uni] ; Erik B. Schelbert [États-Unis] ; Josephine H. Naish [Royaume-Uni] ; Emma Bedson [Royaume-Uni] ; Susanna Dodd [Royaume-Uni] ; Helen Eccleson [Royaume-Uni] ; Dannii Clayton [Royaume-Uni] ; Beatriz Duran Jimenez [Royaume-Uni] ; Theresa Mcdonagh [Royaume-Uni] ; Simon G. Williams [Royaume-Uni] ; Anne Cooper [Royaume-Uni] ; Colin Cunnington [Royaume-Uni] ; Fozia Zahir Ahmed [Royaume-Uni] ; Rajavarma Viswesvaraiah [Royaume-Uni] ; Stuart Russell [Royaume-Uni] ; Stefan Neubauer [Royaume-Uni] ; Paula R. Williamson [Royaume-Uni] ; Christopher A. Miller [Royaume-Uni]

Source :

Cardiovascular drugs and therapy [ 1573-7241 ] ; 2019.

RBID : pubmed:31069575

Descripteurs français

KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Débit systolique (MeSH), Défaillance cardiaque (physiopathologie), Défaillance cardiaque (traitement médicamenteux), Femelle (MeSH), Fibrose (MeSH), Fonction ventriculaire gauche (physiologie), Fragments peptidiques (MeSH), Humains (MeSH), Mâle (MeSH), Méthode en double aveugle (MeSH), Peptide natriurétique cérébral (MeSH), Pyridones (usage thérapeutique), Sujet âgé (MeSH).
MESH :
- physiologie : Fonction ventriculaire gauche.
- physiopathologie : Défaillance cardiaque.
- traitement médicamenteux : Défaillance cardiaque.
- usage thérapeutique : Pyridones.
- Adulte, Adulte d'âge moyen, Débit systolique, Femelle, Fibrose, Fragments peptidiques, Humains, Mâle, Méthode en double aveugle, Peptide natriurétique cérébral, Sujet âgé.

English descriptors

KwdEn :
- Adult (MeSH), Aged (MeSH), Double-Blind Method (MeSH), Female (MeSH), Fibrosis (MeSH), Heart Failure (drug therapy), Heart Failure (physiopathology), Humans (MeSH), Male (MeSH), Middle Aged (MeSH), Natriuretic Peptide, Brain (MeSH), Peptide Fragments (MeSH), Pyridones (therapeutic use), Stroke Volume (MeSH), Ventricular Function, Left (physiology).
MESH :
- chemical , therapeutic use : Pyridones.
- chemical : Natriuretic Peptide, Brain, Peptide Fragments.
- drug therapy : Heart Failure.
- physiology : Ventricular Function, Left.
- physiopathology : Heart Failure.
- Adult, Aged, Double-Blind Method, Female, Fibrosis, Humans, Male, Middle Aged, Stroke Volume.

Abstract

BACKGROUND

The 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.

METHODS

The 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 REGISTRATION

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

DOI: 10.1007/s10557-019-06876-y
PubMed: 31069575
PubMed Central: PMC6689029

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000910
to stream Main, to step Curation: 000910

Le document en format XML

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<author><name sortKey="Bedson, Emma" sort="Bedson, Emma" uniqKey="Bedson E" first="Emma" last="Bedson">Emma Bedson</name>
<affiliation wicri:level="1"><nlm:affiliation>Clinical 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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Clinical 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</wicri:regionArea>
<wicri:noRegion>L12 2AP</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Dodd, Susanna" sort="Dodd, Susanna" uniqKey="Dodd S" first="Susanna" last="Dodd">Susanna Dodd</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL</wicri:regionArea>
<wicri:noRegion>L69 3GL</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Eccleson, Helen" sort="Eccleson, Helen" uniqKey="Eccleson H" first="Helen" last="Eccleson">Helen Eccleson</name>
<affiliation wicri:level="1"><nlm:affiliation>Clinical 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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Clinical 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</wicri:regionArea>
<wicri:noRegion>L12 2AP</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Clayton, Dannii" sort="Clayton, Dannii" uniqKey="Clayton D" first="Dannii" last="Clayton">Dannii Clayton</name>
<affiliation wicri:level="1"><nlm:affiliation>Clinical 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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Clinical 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</wicri:regionArea>
<wicri:noRegion>L12 2AP</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jimenez, Beatriz Duran" sort="Jimenez, Beatriz Duran" uniqKey="Jimenez B" first="Beatriz Duran" last="Jimenez">Beatriz Duran Jimenez</name>
<affiliation wicri:level="1"><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT</wicri:regionArea>
<wicri:noRegion>M23 9LT</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mcdonagh, Theresa" sort="Mcdonagh, Theresa" uniqKey="Mcdonagh T" first="Theresa" last="Mcdonagh">Theresa Mcdonagh</name>
<affiliation wicri:level="1"><nlm:affiliation>King's College Hospital, Denmark Hill, London, SE5 9RS, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>King's College Hospital, Denmark Hill, London, SE5 9RS</wicri:regionArea>
<wicri:noRegion>SE5 9RS</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Williams, Simon G" sort="Williams, Simon G" uniqKey="Williams S" first="Simon G" last="Williams">Simon G. Williams</name>
<affiliation wicri:level="1"><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT</wicri:regionArea>
<wicri:noRegion>M23 9LT</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cooper, Anne" sort="Cooper, Anne" uniqKey="Cooper A" first="Anne" last="Cooper">Anne Cooper</name>
<affiliation wicri:level="1"><nlm:affiliation>Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD</wicri:regionArea>
<wicri:noRegion>M6 8HD</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cunnington, Colin" sort="Cunnington, Colin" uniqKey="Cunnington C" first="Colin" last="Cunnington">Colin Cunnington</name>
<affiliation wicri:level="4"><nlm:affiliation>Division 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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division 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</wicri:regionArea>
<orgName type="university">Université de Manchester</orgName>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT</wicri:regionArea>
<wicri:noRegion>M23 9LT</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ahmed, Fozia Zahir" sort="Ahmed, Fozia Zahir" uniqKey="Ahmed F" first="Fozia Zahir" last="Ahmed">Fozia Zahir Ahmed</name>
<affiliation wicri:level="4"><nlm:affiliation>Division 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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division 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</wicri:regionArea>
<orgName type="university">Université de Manchester</orgName>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT</wicri:regionArea>
<wicri:noRegion>M23 9LT</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Viswesvaraiah, Rajavarma" sort="Viswesvaraiah, Rajavarma" uniqKey="Viswesvaraiah R" first="Rajavarma" last="Viswesvaraiah">Rajavarma Viswesvaraiah</name>
<affiliation wicri:level="1"><nlm:affiliation>Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE</wicri:regionArea>
<wicri:noRegion>SK2 7JE</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Russell, Stuart" sort="Russell, Stuart" uniqKey="Russell S" first="Stuart" last="Russell">Stuart Russell</name>
<affiliation wicri:level="1"><nlm:affiliation>East Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>East Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL</wicri:regionArea>
<wicri:noRegion>SK10 3BL</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Neubauer, Stefan" sort="Neubauer, Stefan" uniqKey="Neubauer S" first="Stefan" last="Neubauer">Stefan Neubauer</name>
<affiliation wicri:level="4"><nlm:affiliation>Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford</wicri:regionArea>
<placeName><settlement type="city">Oxford</settlement>
<region type="country">Angleterre</region>
<region type="comté" nuts="2">Oxfordshire</region>
</placeName>
<orgName type="university">Université d'Oxford</orgName>
</affiliation>
</author>
<author><name sortKey="Williamson, Paula R" sort="Williamson, Paula R" uniqKey="Williamson P" first="Paula R" last="Williamson">Paula R. Williamson</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL</wicri:regionArea>
<wicri:noRegion>L69 3GL</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Miller, Christopher A" sort="Miller, Christopher A" uniqKey="Miller C" first="Christopher A" last="Miller">Christopher A. Miller</name>
<affiliation wicri:level="4"><nlm:affiliation>Division 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.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division 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</wicri:regionArea>
<orgName type="university">Université de Manchester</orgName>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK. Christopher.Miller@manchester.ac.uk.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT</wicri:regionArea>
<wicri:noRegion>M23 9LT</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Wellcome Centre for Cell-Matrix Research, Division of Cell-Matrix Biology and Regenerative Medicine, School of Biology, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PT, UK. Christopher.Miller@manchester.ac.uk.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Wellcome Centre for Cell-Matrix Research, Division of Cell-Matrix Biology and Regenerative Medicine, School of Biology, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PT</wicri:regionArea>
<orgName type="university">Université de Manchester</orgName>
<placeName><settlement type="city">Manchester</settlement>
<region type="nation">Angleterre</region>
<region nuts="2" type="region">Grand Manchester</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Cardiovascular drugs and therapy</title>
<idno type="eISSN">1573-7241</idno>
<imprint><date when="2019" type="published">2019</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Female (MeSH)</term>
<term>Fibrosis (MeSH)</term>
<term>Heart Failure (drug therapy)</term>
<term>Heart Failure (physiopathology)</term>
<term>Humans (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Natriuretic Peptide, Brain (MeSH)</term>
<term>Peptide Fragments (MeSH)</term>
<term>Pyridones (therapeutic use)</term>
<term>Stroke Volume (MeSH)</term>
<term>Ventricular Function, Left (physiology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Débit systolique (MeSH)</term>
<term>Défaillance cardiaque (physiopathologie)</term>
<term>Défaillance cardiaque (traitement médicamenteux)</term>
<term>Femelle (MeSH)</term>
<term>Fibrose (MeSH)</term>
<term>Fonction ventriculaire gauche (physiologie)</term>
<term>Fragments peptidiques (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Peptide natriurétique cérébral (MeSH)</term>
<term>Pyridones (usage thérapeutique)</term>
<term>Sujet âgé (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Pyridones</term>
</keywords>
<keywords scheme="MESH" type="chemical" xml:lang="en"><term>Natriuretic Peptide, Brain</term>
<term>Peptide Fragments</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="physiologie" xml:lang="fr"><term>Fonction ventriculaire gauche</term>
</keywords>
<keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Ventricular Function, Left</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Défaillance cardiaque</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Défaillance cardiaque</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Pyridones</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Fibrosis</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Stroke Volume</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Débit systolique</term>
<term>Femelle</term>
<term>Fibrose</term>
<term>Fragments peptidiques</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Peptide natriurétique cérébral</term>
<term>Sujet âgé</term>
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<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>The 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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>The 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 </p>
</div>
<div type="abstract" xml:lang="en"><p><b>DISCUSSION</b>
</p>
<p>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).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CLINICAL TRIAL REGISTRATION</b>
</p>
<p>clinicaltrials.gov (NCT02932566) https://clinicaltrials.gov/ct2/show/NCT02932566.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">31069575</PMID>
<DateCompleted><Year>2020</Year>
<Month>05</Month>
<Day>20</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>05</Month>
<Day>20</Day>
</DateRevised>
<Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1573-7241</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>33</Volume>
<Issue>4</Issue>
<PubDate><Year>2019</Year>
<Month>08</Month>
</PubDate>
</JournalIssue>
<Title>Cardiovascular drugs and therapy</Title>
<ISOAbbreviation>Cardiovasc Drugs Ther</ISOAbbreviation>
</Journal>
<ArticleTitle>Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.</ArticleTitle>
<Pagination><MedlinePgn>461-470</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1007/s10557-019-06876-y</ELocationID>
<Abstract><AbstractText Label="BACKGROUND">The 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.</AbstractText>
<AbstractText Label="METHODS">The 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 <sup>31</sup>
phosphorus magnetic resonance spectroscopy.</AbstractText>
<AbstractText Label="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).</AbstractText>
<AbstractText Label="CLINICAL TRIAL REGISTRATION">clinicaltrials.gov (NCT02932566) https://clinicaltrials.gov/ct2/show/NCT02932566.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lewis</LastName>
<ForeName>Gavin A</ForeName>
<Initials>GA</Initials>
<AffiliationInfo><Affiliation>Division 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.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Schelbert</LastName>
<ForeName>Erik B</ForeName>
<Initials>EB</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>UPMC Cardiovascular Magnetic Resonance Center, Heart and Vascular Institute, Pittsburgh, PA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Naish</LastName>
<ForeName>Josephine H</ForeName>
<Initials>JH</Initials>
<AffiliationInfo><Affiliation>Division 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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bedson</LastName>
<ForeName>Emma</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Clinical 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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dodd</LastName>
<ForeName>Susanna</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Block F, Waterhouse Bld, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Eccleson</LastName>
<ForeName>Helen</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Clinical 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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Clayton</LastName>
<ForeName>Dannii</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Clinical 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.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jimenez</LastName>
<ForeName>Beatriz Duran</ForeName>
<Initials>BD</Initials>
<AffiliationInfo><Affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McDonagh</LastName>
<ForeName>Theresa</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>King's College Hospital, Denmark Hill, London, SE5 9RS, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Williams</LastName>
<ForeName>Simon G</ForeName>
<Initials>SG</Initials>
<AffiliationInfo><Affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cooper</LastName>
<ForeName>Anne</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cunnington</LastName>
<ForeName>Colin</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Division 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.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ahmed</LastName>
<ForeName>Fozia Zahir</ForeName>
<Initials>FZ</Initials>
<AffiliationInfo><Affiliation>Division 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.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</Affiliation>
</AffiliationInfo>
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   |texte=   Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.
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Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.

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

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