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Cardiovascular medicine
Protocol
Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a study protocol for a prospective multicentre trial
  1. Takekazu Miyoshi1,
  2. Yasuki Maeno2,
  3. Haruhiko Sago3,
  4. Noboru Inamura4,
  5. Satoshi Yasukochi5,
  6. Motoyoshi Kawataki6,
  7. Hitoshi Horigome7,
  8. Hitoshi Yoda8,
  9. Mio Taketazu9,
  10. Makio Shozu10,
  11. Masaki Nii11,
  12. Akiko Hagiwara12,
  13. Hitoshi Kato13,
  14. Wataru Shimizu14,
  15. Isao Shiraishi15,
  16. Heima Sakaguchi15,
  17. Keiko Ueda1,
  18. Shinji Katsuragi1,
  19. Tomoaki Ikeda16,
  20. Haruko Yamamoto17,
  21. Toshimitsu Hamasaki18
  22. Japan Fetal Arrhythmia Group
  1. 1 Department of Perinatology and Gynecology, National Cerebral and Cardiovascular Center (NCVC), Suita, Japan
  2. 2 Department of Pediatrics and Child Health, Kurume University School of Medicine, Kurume, Japan
  3. 3 Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan
  4. 4 Department of Pediatric Cardiology, Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Japan
  5. 5 Department of Cardiology, Nagano Children’s Hospital, Azumino, Japan
  6. 6 Department of Neonatology, Kanagawa Children’s Medical Center, Yokohama, Japan
  7. 7 Department of Pediatrics, University of Tsukuba, Tsukuba, Japan
  8. 8 Department of Neonatology, Toho University Omori Medical Center, Tokyo, Japan
  9. 9 Department of Pediatric Cardiology, Saitama Medical University International Medical Center, Hidaka, Japan
  10. 10 Department of Obstetrics and Gynecology, Chiba University, Chiba, Japan
  11. 11 Department of Cardiology, Shizuoka Children’s Hospital, Shizuoka, Japan
  12. 12 Department of Internal Medicine, Kanagawa Children’s Medical Center, Yokohama, Japan
  13. 13 Department of Pediatric Cardiology, National Center for Child Health and Development, Tokyo, Japan
  14. 14 Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan
  15. 15 Department of Pediatric Cardiology, NCVC, Suita, Japan
  16. 16 Department of Obstetrics and Gynecology, Mie University, Tsu, Japan
  17. 17 Center for Advancing Clinical and Translational Sciences, NCVC, Suita, Japan
  18. 18 Department of Data Science, NCVC, Suita, Japan
  1. Correspondence to Dr Yasuki Maeno; yasukim{at}med.kurume-u.ac.jp

Abstract

Introduction Several retrospective or single-centre studies demonstrated the efficacy of transplacental treatment of fetal tachyarrhythmias. Our retrospective nationwide survey showed that the fetal therapy will be successful at an overall rate of 90%. For fetuses with hydrops, the treatment success rate will be 80%. However, standard protocol has not been established. The objective of this study is to evaluate the efficacy and safety of the protocol-defined transplacental treatment of fetal tachyarrhythmias. Participant recruitment began in October 2010.

Methods and analysis The current study is a multicentre, single-arm interventional study. A total of 50 fetuses will be enrolled from 15 Japanese institutions. The protocol-defined transplacental treatment is performed for singletons with sustained fetal tachyarrhythmia ≥180 bpm, with a diagnosis of supraventricular tachycardia or atrial flutter. Digoxin, sotalol, flecainide or a combination is used for transplacental treatment. The primary endpoint is disappearance of fetal tachyarrhythmias. The secondary endpoints are fetal death related to tachyarrhythmia, proportion of preterm birth, rate of caesarean section attributable to fetal arrhythmia, improvement in fetal hydrops, neonatal arrhythmia, neonatal central nervous system disorders and neonatal survival. Maternal, fetal and neonatal adverse events are evaluated at 1 month after birth. Growth and development are also evaluated at 18 and 36 months of corrected age.

Ethics and dissemination The Institutional Review Board of the National Cerebral and Cardiovascular Center of Japan has approved this study. Our findings will be widely disseminated through conference presentations and peer-reviewed publications.

Trial registration number UMIN Clinical Trials Registry UMIN000004270.

  • atrial flutter
  • fetal tachyarrhythmias
  • supraventricular tachycardia
  • transplacental treatment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016597

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    Footnotes

    • Contributors TM, YM, HS, NI, SY, MK, HH, HY, MT, MS, MN, AH, HK, WS, IS, HS, KU, SK, TI, HY and TH: conception of the study. TM: writing of the manuscript. KU and HY: coordination of the study. TH: statistical analysis and providing the biostatistical study design. SY, WS, YM and TI: members of the Protocol Evaluation Committee. YM and TI: corresponding to this trial. HS: supervision and the grant holder.

    • Funding This work was supported by a grant from the Ministry of Health, Labor and Welfare of Japan (Health and Labour Science Research Grants for Clinical Research for New Medicine) (H19-009, H23-004), and in part by a grant from the Takeda Science Foundation (J042) and Tsuchiya Foundation (J151).

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The Institutional Review Board of the National Cerebral and Cardiovascular Center of Japan.

    • Provenance and peer review Not commissioned; externally peer reviewed.