The effect of spironolactone on cardiovascular function and markers of fibrosis in people at increased risk of developing heart failure: the heart ‘OMics’ in AGEing (HOMAGE) randomized clinical trial
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- John G F Cleland
- Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary , Glasgow G12 8QQ, UK
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- João Pedro Ferreira
- Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy , F-CRIN INI-CRCT, Nancy, U1116, France
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- Beatrice Mariottoni
- Department of Cardiology, Cortona Hospital , Arezzo, Italy
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- Pierpaolo Pellicori
- Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary , Glasgow G12 8QQ, UK
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- Joe Cuthbert
- Department of Cardiology, University of Hull, Castle Hill Hospital, Cottingham , East Riding of Yorkshire, UK
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- Job A J Verdonschot
- Department of Cardiology, Maastricht University Medical Center , the Netherlands
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- Johannes Petutschnigg
- Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin Institute of Health (BIH), and German Centre for Cardiovascular research (DZHK) , Partner Site Berlin, Germany
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- Fozia Z Ahmed
- 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, UK
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- Franco Cosmi
- Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy , F-CRIN INI-CRCT, Nancy, U1116, France
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- Hans-Peter Brunner La Rocca
- Department of Cardiology, Maastricht University Medical Center , the Netherlands
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- Mamas A Mamas
- 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, UK
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- Andrew L Clark
- Department of Cardiology, University of Hull, Castle Hill Hospital, Cottingham , East Riding of Yorkshire, UK
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- Frank Edelmann
- Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin Institute of Health (BIH), and German Centre for Cardiovascular research (DZHK) , Partner Site Berlin, Germany
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- Burkert Pieske
- Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin Institute of Health (BIH), and German Centre for Cardiovascular research (DZHK) , Partner Site Berlin, Germany
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- Javed Khan
- Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary , Glasgow G12 8QQ, UK
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- Ken McDonald
- St. Vincent's University Healthcare Group, and School of Medicine, University College Dublin , Dublin, Ireland
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- Philippe Rouet
- Equipe obésité et insuffisance cardiaque, Université UPS, Inserm I2MC , Toulouse, UMR 1048, France
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- Jan A Staessen
- Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, University of Leuven , Leuven, Belgium
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- Blerim Mujaj
- Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, University of Leuven , Leuven, Belgium
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- Arantxa González
- Program of Cardiovascular Diseases, CIMA. Universidad de Navarra and IdiSNA, Pamplona, Spain CIBERCV, Carlos III Institute of Health , Madrid, Spain
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- Javier Diez
- Program of Cardiovascular Diseases, CIMA. Universidad de Navarra and IdiSNA, Pamplona, Spain CIBERCV, Carlos III Institute of Health , Madrid, Spain
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- Mark Hazebroek
- Department of Cardiology, Maastricht University Medical Center , the Netherlands
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- Stephane Heymans
- Department of Cardiology, Maastricht University Medical Center , the Netherlands
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- Roberto Latini
- Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche “Mario Negri” – IRCCS , Milan, Italy
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- Stéphanie Grojean
- Fondation Force, Research and Consulting Department, EDDH, Centre de Médecine Préventive, Rue du Doyen Jacques Parisot , Vandoeuvre les Nancy, 54500, France
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- Anne Pizard
- Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy , F-CRIN INI-CRCT, Nancy, U1116, France
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- Nicolas Girerd
- Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy , F-CRIN INI-CRCT, Nancy, U1116, France
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- Patrick Rossignol
- Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy , F-CRIN INI-CRCT, Nancy, U1116, France
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- Tim J Collier
- Department of Medical Statistics, London School of Hygiene and Tropical Medicine , London, UK
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- Faiez Zannad
- Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy , F-CRIN INI-CRCT, Nancy, U1116, France
抄録
<jats:title>Abstract</jats:title><jats:sec><jats:title>Aims </jats:title><jats:p>To investigate the effects of spironolactone on fibrosis and cardiac function in people at increased risk of developing heart failure.</jats:p></jats:sec><jats:sec><jats:title>Methods and results </jats:title><jats:p>Randomized, open-label, blinded-endpoint trial comparing spironolactone (50 mg/day) or control for up to 9 months in people with, or at high risk of, coronary disease and raised plasma B-type natriuretic peptides. The primary endpoint was the interaction between baseline serum galectin-3 and changes in serum procollagen type-III N-terminal pro-peptide (PIIINP) in participants assigned to spironolactone or control. Procollagen type-I C-terminal pro-peptide (PICP) and collagen type-1 C-terminal telopeptide (CITP), reflecting synthesis and degradation of type-I collagen, were also measured. In 527 participants (median age 73 years, 26% women), changes in PIIINP were similar for spironolactone and control [mean difference (mdiff): −0.15; 95% confidence interval (CI) −0.44 to 0.15 μg/L; P = 0.32] but those receiving spironolactone had greater reductions in PICP (mdiff: −8.1; 95% CI −11.9 to −4.3 μg/L; P < 0.0001) and PICP/CITP ratio (mdiff: −2.9; 95% CI −4.3 to −1.5; <0.0001). No interactions with serum galectin were observed. Systolic blood pressure (mdiff: −10; 95% CI −13 to −7 mmHg; P < 0.0001), left atrial volume (mdiff: −1; 95% CI −2 to 0 mL/m2; P = 0.010), and NT-proBNP (mdiff: −57; 95% CI −81 to −33 ng/L; P < 0.0001) were reduced in those assigned spironolactone.</jats:p></jats:sec><jats:sec><jats:title>Conclusions </jats:title><jats:p>Galectin-3 did not identify greater reductions in serum concentrations of collagen biomarkers in response to spironolactone. However, spironolactone may influence type-I collagen metabolism. Whether spironolactone can delay or prevent progression to symptomatic heart failure should be investigated.</jats:p><jats:p /></jats:sec>
収録刊行物
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- European Heart Journal
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European Heart Journal 42 (6), 684-696, 2020-11-20
Oxford University Press (OUP)