TY - JOUR
T1 - Antenatal antiarrhythmic treatment for fetal tachyarrhythmias
T2 - A study protocol for a prospective multicentre trial
AU - Japan Fetal Arrhythmia Group
AU - Miyoshi, Takekazu
AU - Maeno, Yasuki
AU - Sago, Haruhiko
AU - Inamura, Noboru
AU - Yasukochi, Satoshi
AU - Kawataki, Motoyoshi
AU - Horigome, Hitoshi
AU - Yoda, Hitoshi
AU - Taketazu, Mio
AU - Shozu, Makio
AU - Nii, Masaki
AU - Hagiwara, Akiko
AU - Kato, Hitoshi
AU - Shimizu, Wataru
AU - Shiraishi, Isao
AU - Sakaguchi, Heima
AU - Ueda, Keiko
AU - Katsuragi, Shinji
AU - Ikeda, Tomoaki
AU - Yamamoto, Haruko
AU - Hamasaki, Toshimitsu
N1 - Funding Information:
Based on the above, we have designed this clinical study to establish evidence for fetal tachyarrhythmia therapy. With the participation of many major medical centres providing fetal therapy, this study will evaluate the safety and effectiveness of the protocol developed by the Fetal Arrhythmia Group of the Research Team for Evidence-Based Fetal Therapy (principal investigator: Dr Sago), which was funded under the Health Labour Science Research Grant Program in Japan. The retrospective survey mentioned earlier presents current clinical results of fetal therapy in Japan, which are expected to serve as the control for this prospective study. These data and historical control data from the literature were referenced in designing this clinical study. Therefore, we planned a multicentre single-arm interventional study to confirm the efficacy and safety of the protocol-defined transplacental treatment of fetal tachyarrhythmias.
Publisher Copyright:
© 2017 Article author(s). All rights reserved.
PY - 2017/8/1
Y1 - 2017/8/1
N2 - 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.
AB - 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.
KW - atrial flutter
KW - fetal tachyarrhythmias
KW - supraventricular tachycardia
KW - transplacental treatment
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U2 - 10.1136/bmjopen-2017-016597
DO - 10.1136/bmjopen-2017-016597
M3 - Article
C2 - 28851790
AN - SCOPUS:85041293550
VL - 7
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 8
M1 - e016597
ER -