دورية أكاديمية
أعرض في EDS

Rationale and design of a randomised trial of intravenous iron in patients with heart failure.

التفاصيل البيبلوغرافية
العنوان: Rationale and design of a randomised trial of intravenous iron in patients with heart failure.
المؤلفون: Kalra PR; Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK., Cleland JG; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK., Petrie MC; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.; Golden Jubilee National Hospital, Clydebank, UK., Ahmed FZ; Division of Cardiovascular Sciences, The University of Manchester Faculty of Biology Medicine and Health, Manchester, UK., Foley PW; Great Western Hospital, Swindon, UK., Kalra PA; Department of Renal Medicine, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK., Lang NN; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK., Lane RE; Part of Guy's and St Thomas' NHS Foundation Trust, Royal Brompton and Harefield Hospitals, London, UK., Macdougall IC; Department of Renal Medicine, King's College Hospital, London, UK., Pellicori P; Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK., Pope MTB; Department of Cardiology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Robertson M; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK., Squire IB; Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.; NIHR Leicester Biomedical Research Centre Cardiovascular Diseases, Leicester, UK., Thomson EA; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK., Ford I; Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK ian.ford@glasgow.ac.uk.
المصدر: Heart (British Cardiac Society) [Heart] 2022 Nov 24; Vol. 108 (24), pp. 1979-1985. Date of Electronic Publication: 2022 Nov 24.
نوع المنشور: Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Pub. Group Country of Publication: England NLM ID: 9602087 Publication Model: Electronic Cited Medium: Internet ISSN: 1468-201X (Electronic) Linking ISSN: 13556037 NLM ISO Abbreviation: Heart Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BMJ Pub. Group, c1996-
مواضيع طبية MeSH: Heart Failure* , Iron Deficiencies* , Heart Failure, Systolic*, Humans ; Adolescent ; Adult ; Stroke Volume ; Iron ; Prospective Studies ; Ventricular Function, Left ; Ferritins/therapeutic use
مستخلص: Objectives: For patients with a reduced left ventricular ejection fraction (LVEF) heart failure with reduced ejection fraction (HFrEF) and iron deficiency, administration of intravenous iron improves symptoms, exercise capacity and may in the following 12 months, reduce hospitalisations for heart failure. The Effectiveness of I nt r avenous ir on treat m ent versus standard care in p a tie n ts with heart failure and iron deficiency (IRONMAN) trial evaluated whether the benefits of intravenous iron persist in the longer term and impact on morbidity and mortality.
Methods: IRONMAN is a prospective, randomised, open-label, blinded endpoint (PROBE) event-driven trial. Patients aged ≥18 years with HFrEF (LVEF ≤45%) and evidence of iron deficiency (ferritin <100 µg/L and/or TSAT <20%) were enrolled if they had either a current or recent hospitalisation for heart failure or elevated plasma concentrations of a natriuretic peptide. Participants were randomised to receive, or not to receive, intravenous ferric derisomaltose in addition to guideline-recommended therapy for HFrEF. Every 4 months, intravenous iron was administered if either ferritin was <100 µg/L or, provided ferritin was ≤400 µg/L, TSAT was <25%. The primary endpoint is a composite of total hospitalisations for heart failure and cardiovascular death. Hospitalisation and deaths due to infection are safety endpoints.
Results: Trial recruitment was completed across 70 UK hospital sites in October 2021. Participants were followed until the end of March 2022. We plan to report the results by November 2022.
Conclusions: IRONMAN will determine whether repeated doses of intravenous ferric derisomaltose are beneficial and safe for the long-term treatment of a broad range of patients with HFrEF and iron deficiency.
Trial Registration Number: NCT02642562.
Competing Interests: Competing interests: PRK: research grant support from British Heart Foundation, Pharmacosmos and Vifor; consultancy fees from Ackea, Amgem, Bayer, Boehringer Ingelheim, Boston Scientific, Napp, Novartis, Pharmacosmos, Servier and Vifor; payment for lectures from AstraZeneca, Bayer, Novartis, Pharmacosmos and Vifor; support for attending meetings from Pharmacosmos; has served as Chair of the British Society for Heart Failure. JGC: research grant support from Amgen, Bayer, Bristol Myers Squibb, Vifor, Pharmacosmos, Cytokinetics, Johnson & Johnson, MyoKardia, Stealth Biopharmaceuticals and Viscardia; honoraria from Abbott, Amgen, Bayer, Bristol Myers Squibb, Novartis, Medtronic, Idorsia, Vifor, Pharmacosmos, Cytokinetics, Servier, Boehringer Ingelheim, AstraZeneca, Innolife, Torrent, Johnson & Johnson, MyoKardia, Respicardia, Stealth Biopharmaceuticals, Viscardia and NI Medical. MCP: research funding from Boehringer Ingelheim, Roche, SQ Innovations, AstraZeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific and Pharmacosmos. Consultancy, payment for lectures and clinical trials committees: Boehringer Ingelheim, Novartis, AstraZeneca, Novo Nordisk, Medtronic, Abbvie, Bayer, Takeda, Cardiorentis, Pharmacosmos, Siemens, SQ Innovations and Vifor; MCP is supported by the British Heart Foundation (BHF) Centre of Research Excellence Award (RE/13/5/30177 and RE/18/6/34217+). FA: Research funding from Medtronic; consultancy fees from AstraZeneca, Medtronic, Pfizer, Pharmacosmos, Servier and Vifor; support for attending meetings from AstraZeneca, Medtronic, Pharmacosmos and Vifor. PF: payment for lectures from Vifor and Pharmacosmos; support for attending meetings from Pharmacosmos. PAK: research grant support from Pharmacosmos, Vifor, Astellas, Unicyte and Evotec; consultancy fees from Vifor, Pharmacosmos, AstraZeneca, Napp, Pfizer and Bayer; support for attending meetings from Pharmacosmos and Vifor. NNL: research grant support from Roche Diagnostics, British Heart Foundation, AstraZeneca, Tenovus Scotland and Boehringer Ingelheim; consultancy fees from AstraZeneca; payment for lectures from Roche Pharma, Pfizer and Novartis; participation on a DSM/advisory board for Pharmacosmos; Associate Editor of Circulation: Heart Failure. RL: payment for lectures from Boston Scientific. ICM: consultancy fees from GlaxoSmithKline and Vifor; steering committee member for GlaxoSmithKline trials. PP: research grant support from British Heart Foundation; consultancy fees from Pharmacosmos, Novartis, Vifor and AstraZeneca; support for attending meetings from Boehringer Ingelheim and Vifor. MTBP: none. MR: research grant support from British Heart Foundation, Pharmacosmos. IBS: payment for lectures from Novartis, Merck, AstraZeneca and Boehringer Ingelheim; expert advisory role on NICE COVID RAPID Guidelines Committee. EAT: research grant support from British Heart Foundation and Pharmacosmos. IF: research grant support from British Heart Foundation, Pharmacosmos and Vifor.
(© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)
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معلومات مُعتمدة: CS/15/1/31175 United Kingdom BHF_ British Heart Foundation
فهرسة مساهمة: Keywords: Heart Failure; Heart Failure, Systolic
سلسلة جزيئية: ClinicalTrials.gov NCT02642562
المشرفين على المادة: AHU547PI9H (ferric derisomaltose)
E1UOL152H7 (Iron)
9007-73-2 (Ferritins)
تواريخ الأحداث: Date Created: 20220810 Date Completed: 20221128 Latest Revision: 20221209
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC9726969
DOI: 10.1136/heartjnl-2022-321304
PMID: 35948408
قاعدة البيانات: MEDLINE
الوصف
تدمد:1468-201X
DOI:10.1136/heartjnl-2022-321304