Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.
Identifieur interne : 000910 ( Main/Corpus ); précédent : 000909; suivant : 000911Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.
Auteurs : 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 ; Anne Cooper ; Colin Cunnington ; Fozia Zahir Ahmed ; Rajavarma Viswesvaraiah ; Stuart Russell ; Stefan Neubauer ; Paula R. Williamson ; Christopher A. MillerSource :
- Cardiovascular drugs and therapy [ 1573-7241 ] ; 2019.
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
Links to Exploration step
pubmed:31069575Le document en format XML
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Schelbert</name><affiliation><nlm:affiliation>Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>UPMC Cardiovascular Magnetic Resonance Center, Heart and Vascular Institute, Pittsburgh, PA, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Naish, Josephine H" sort="Naish, Josephine H" uniqKey="Naish J" first="Josephine H" last="Naish">Josephine H. Naish</name><affiliation><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></affiliation></author><author><name sortKey="Bedson, Emma" sort="Bedson, Emma" uniqKey="Bedson E" first="Emma" last="Bedson">Emma Bedson</name><affiliation><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></affiliation></author><author><name sortKey="Dodd, Susanna" sort="Dodd, Susanna" uniqKey="Dodd S" first="Susanna" last="Dodd">Susanna Dodd</name><affiliation><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></affiliation></author><author><name sortKey="Eccleson, Helen" sort="Eccleson, Helen" uniqKey="Eccleson H" first="Helen" last="Eccleson">Helen Eccleson</name><affiliation><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></affiliation></author><author><name sortKey="Clayton, Dannii" sort="Clayton, Dannii" uniqKey="Clayton D" first="Dannii" last="Clayton">Dannii Clayton</name><affiliation><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></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><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mcdonagh, Theresa" sort="Mcdonagh, Theresa" uniqKey="Mcdonagh T" first="Theresa" last="Mcdonagh">Theresa Mcdonagh</name><affiliation><nlm:affiliation>King's College Hospital, Denmark Hill, London, SE5 9RS, UK.</nlm:affiliation></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><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cooper, Anne" sort="Cooper, Anne" uniqKey="Cooper A" first="Anne" last="Cooper">Anne Cooper</name><affiliation><nlm:affiliation>Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cunnington, Colin" sort="Cunnington, Colin" uniqKey="Cunnington C" first="Colin" last="Cunnington">Colin Cunnington</name><affiliation><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></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><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Viswesvaraiah, Rajavarma" sort="Viswesvaraiah, Rajavarma" uniqKey="Viswesvaraiah R" first="Rajavarma" last="Viswesvaraiah">Rajavarma Viswesvaraiah</name><affiliation><nlm:affiliation>Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Russell, Stuart" sort="Russell, Stuart" uniqKey="Russell S" first="Stuart" last="Russell">Stuart Russell</name><affiliation><nlm:affiliation>East Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Neubauer, Stefan" sort="Neubauer, Stefan" uniqKey="Neubauer S" first="Stefan" last="Neubauer">Stefan Neubauer</name><affiliation><nlm:affiliation>Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></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><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></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><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK. Christopher.Miller@manchester.ac.uk.</nlm:affiliation></affiliation><affiliation><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></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2019">2019</date><idno type="RBID">pubmed:31069575</idno><idno type="pmid">31069575</idno><idno type="doi">10.1007/s10557-019-06876-y</idno><idno type="pmc">PMC6689029</idno><idno type="wicri:Area/Main/Corpus">000910</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000910</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.</title><author><name sortKey="Lewis, Gavin A" sort="Lewis, Gavin A" uniqKey="Lewis G" first="Gavin A" last="Lewis">Gavin A. Lewis</name><affiliation><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Schelbert, Erik B" sort="Schelbert, Erik B" uniqKey="Schelbert E" first="Erik B" last="Schelbert">Erik B. Schelbert</name><affiliation><nlm:affiliation>Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>UPMC Cardiovascular Magnetic Resonance Center, Heart and Vascular Institute, Pittsburgh, PA, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Naish, Josephine H" sort="Naish, Josephine H" uniqKey="Naish J" first="Josephine H" last="Naish">Josephine H. Naish</name><affiliation><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></affiliation></author><author><name sortKey="Bedson, Emma" sort="Bedson, Emma" uniqKey="Bedson E" first="Emma" last="Bedson">Emma Bedson</name><affiliation><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></affiliation></author><author><name sortKey="Dodd, Susanna" sort="Dodd, Susanna" uniqKey="Dodd S" first="Susanna" last="Dodd">Susanna Dodd</name><affiliation><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></affiliation></author><author><name sortKey="Eccleson, Helen" sort="Eccleson, Helen" uniqKey="Eccleson H" first="Helen" last="Eccleson">Helen Eccleson</name><affiliation><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></affiliation></author><author><name sortKey="Clayton, Dannii" sort="Clayton, Dannii" uniqKey="Clayton D" first="Dannii" last="Clayton">Dannii Clayton</name><affiliation><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></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><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Mcdonagh, Theresa" sort="Mcdonagh, Theresa" uniqKey="Mcdonagh T" first="Theresa" last="Mcdonagh">Theresa Mcdonagh</name><affiliation><nlm:affiliation>King's College Hospital, Denmark Hill, London, SE5 9RS, UK.</nlm:affiliation></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><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cooper, Anne" sort="Cooper, Anne" uniqKey="Cooper A" first="Anne" last="Cooper">Anne Cooper</name><affiliation><nlm:affiliation>Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Cunnington, Colin" sort="Cunnington, Colin" uniqKey="Cunnington C" first="Colin" last="Cunnington">Colin Cunnington</name><affiliation><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></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><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Viswesvaraiah, Rajavarma" sort="Viswesvaraiah, Rajavarma" uniqKey="Viswesvaraiah R" first="Rajavarma" last="Viswesvaraiah">Rajavarma Viswesvaraiah</name><affiliation><nlm:affiliation>Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Russell, Stuart" sort="Russell, Stuart" uniqKey="Russell S" first="Stuart" last="Russell">Stuart Russell</name><affiliation><nlm:affiliation>East Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Neubauer, Stefan" sort="Neubauer, Stefan" uniqKey="Neubauer S" first="Stefan" last="Neubauer">Stefan Neubauer</name><affiliation><nlm:affiliation>Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.</nlm:affiliation></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><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></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><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></affiliation><affiliation><nlm:affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK. Christopher.Miller@manchester.ac.uk.</nlm:affiliation></affiliation><affiliation><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></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></biblStruct></sourceDesc></fileDesc><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="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="physiology" xml:lang="en"><term>Ventricular Function, Left</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Heart Failure</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></textClass></profileDesc></teiHeader><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></Author><Author ValidYN="Y"><LastName>Viswesvaraiah</LastName><ForeName>Rajavarma</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Stockport NHS Foundation Trust, Stepping Hill Hospital, Poplar Grove, Hazel Grove, Stockport, SK2 7JE, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Russell</LastName><ForeName>Stuart</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>East Cheshire NHS Trust, Victoria Road, Macclesfield, SK10 3BL, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Neubauer</LastName><ForeName>Stefan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Williamson</LastName><ForeName>Paula R</ForeName><Initials>PR</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>Miller</LastName><ForeName>Christopher A</ForeName><Initials>CA</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. Christopher.Miller@manchester.ac.uk.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Manchester University NHS Foundation Trust, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK. Christopher.Miller@manchester.ac.uk.</Affiliation></AffiliationInfo><AffiliationInfo><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. 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MajorTopicYN="N">Fibrosis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006333" MajorTopicYN="N">Heart Failure</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020097" MajorTopicYN="N">Natriuretic Peptide, Brain</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010446" MajorTopicYN="N">Peptide Fragments</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011728" MajorTopicYN="N">Pyridones</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic 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