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鉄欠乏による心不全における静脈内鉄炭酸カルボキシマルトース: FAIR- HF2 DZHK05 ランダム化臨床試験

Stefan D Anker ^1,2, Tim Friede ^3,4, Javed Butler ^5,6

¹Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany.
²Institute of Health Centre for Regenerative Therapies, German Centre for Cardiovascular Research, partner site Charité Universitätsmedizin, Berlin, Germany.
³Department of Medical Statistics, University Medical Centre Göttingen, Göttingen, Germany.
⁴German Centre for Cardiovascular Research, partner site Lower Saxony, Germany.
⁵Department of Medicine, University of Mississippi Medical Center, Jackson.
⁶Baylor Scott and White Research Institute, Dallas, Texas.
⁷Department of Cardiology, Loyola University Medical Centre, Maywood, Illinois.
⁸Department of Intensive Care Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
⁹Department of Medical Informatics, University Medical Centre Göttingen, Göttingen, Germany.
¹⁰University Heart and Vascular Centre Hamburg, Department of Cardiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
¹¹German Centre for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Hamburg, Germany.
¹²Heart Institute, Hospital Universitari Germans Trias i Pujol, CIBERCV, Barcelona, Spain.
¹³Department of Medicine III and Homburg Institute for Cardio, Renal, and Metabolic Medicine, Saarland University, Homburg, Germany.
¹⁴Heart Research Institute, Sydney, Australia.
¹⁵Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany.
¹⁶German Centre for Cardiovascular Research, partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.
¹⁷Department of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
¹⁸Department of Cardiology and Pneumology, University Medical Centre Göttingen, Georg August University of Göttingen, Göttingen, Germany.
¹⁹Division of Cardiology, General Hospital Murska Sobota, Murska Sobota, Slovenia.
²⁰Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
²¹Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany.
²²Berlin Institute of Health, Berlin, Germany.
²³Department of Renal Medicine, King's College Hospital, London, England.
²⁴Heart and Vascular Centre, Semmelweis University, Budapest, Hungary.
²⁵Division of Cardiology, Department of Internal Medicine, University Medicine Rostock, Rostock, Germany.
²⁶Centro Academico de Medicina de Lisboa, CCUL@RISE, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
²⁷West German Heart and Vascular Centre, Department of Cardiology and Vascular Medicine, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
²⁸Coronado Research, Newcastle, England.
²⁹Department of Human Sciences and Promotion of Quality of Life, San Raffaele Open University of Rome, Rome, Italy.
³⁰Cardiology, San Raffaele Cassino Hospital, Cassino, Italy.
³¹IRCCS San Raffaele Roma, Rome, Italy.
³²School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland.
³³Berlin Institute of Health-Centre for Regenerative Therapies and Department of Cardiology, Deutsches Herzzentrum der Charité and German Centre for Cardiovascular Research, partner site Charité-Universitätsmedizin Berlin, Berlin, Germany.
³⁴Department of Cardiology, Angiology, and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany.
³⁵Centre for Cardiovascular Telemedicine, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
³⁶Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
³⁷Baylor Scott and White Health, Heart Hospital, Plano, Texas.
³⁸Department of Cardiology, Cardiology I, University Medical Centre Mainz, Mainz, Germany.
³⁹German Centre for Cardiovascular Research, Standort RheinMain, Frankfurt, Germany.
⁴⁰Technical University of Munich, School of Medicine and Health, Department of Cardiovascular Diseases, German Heart Centre Munich, TUM University Hospital, Munich, Germany.
⁴¹German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany.
⁴²Department of Cardiology, Angiology, Haemostaseology, and Medical Intensive Care, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
⁴³German Centre for Cardiovascular Research, partner site Heidelberg/Mannheim, Mannheim, Germany.
⁴⁴Department of Cardiology, Angiology, and Intensive Care Medicine, University Heart Centre Lübeck, Medical Clinic II, University Hospital Schleswig-Holstein, Lübeck, Germany.
⁴⁵Oświęcimskie Centrum Badań Klinicznych, Oświęcim, Poland.
⁴⁶Department of Cardiology, Angiology, and Pneumolgy, Clinical Trial Unit, University Hospital Heidelberg, Heidelberg, Germany.
⁴⁷Department of Medicine I, LMU University Hospital, LMU Munich, Munich, Germany.
⁴⁸Department of Internal Medicine I, Technical University Munich University Hospital, Munich, Germany.
⁴⁹Institute of Heart Diseases, Medical University and University Hospital, Wroclaw, Poland.

⁰Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany.

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2025年3月30日

PubMedで要約を見る

まとめ

鉄炭酸カルボキシマルトースは,心不全や鉄欠乏の患者の心血管疾患による入院を有意に減少させなかった. この集団における静脈内鉄療法の役割を明らかにするためにさらなる研究が必要である.

科学分野

心臓病科
血液学
臨床試験

背景

鉄欠乏症は心不全の患者でよく見られる.
この集団における静脈内鉄補給の有効性は不明である.
心不全の治療には鉄欠乏症のような併発性疾患の治療も含まれます

研究の目的

心不全と鉄欠乏症と診断された患者における鉄カルボキシマルトースの有効性と安全性を評価する.
鉄炭酸カルボキシマルトースが心血管疾患による死亡や心不全による入院を減少させるかどうかを判断する.
重度の鉄欠乏症 (トランスフェリン飽和度 < 20%) の患者に対する鉄カルボキシマルトースの影響を評価する.

主な方法

1105人の心臓機能不全と鉄欠乏症の患者が参加した多中心のランダム化臨床試験です
参加者は鉄炭酸カルボキシマルトースを静脈内投与か,塩素プラセボを投与した.
心血管疾患による死亡または心不全の入院までの時間を含む主要なエンドポイントを評価し,追跡期間は平均16. 6ヶ月でした.

主要な成果

鉄炭酸カルボキシマルトースは,心血管疾患による死亡または最初の心臓不全の入院までの主要エンドポイントを有意に減少させなかった (HR,0. 79; P=. 04).
心不全全の入院も有意に減少しなかった (RR,0. 80;P=. 12).
鉄炭酸カルボキシマルトース群とプラセボ群の間で,重篤な有害事象の有意な違いは観察されなかった.

結論

鉄カルボキシマルトースは,心臓血管疾患による死亡や心不全による入院を減少させるのに有意な効果を示さなかった.
この治療は,トランスファーリン飽和度が20%未満の患者でも有意な効果を示さなかった.
鉄炭酸カルボキシマルトースの安全性は,この研究集団におけるプラセボと同等であった.

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