Last Updated：04 1月. 2015
Clinical trial of antenatal anti-arrhythmic treatment for fetal tachycarrhythmias
What is the purpose of this clinical trial?+ SHOW
Recently, some reports have shown the effectiveness of fetal therapy to the fetal tachyarrhythmia. However the detailed treatment method or strategy have not been established yet. This clinical trial aims to evaluate the effectiveness and safety of fetal therapy to the fetal tachyarrhythmia.
What is the inclusion criteria for participation in the clinical trial?+ SHOW
1. Sustained fetal heart rate of 180bpm or faster, with either of the following diagnosed:
(1) Atrial flutter
(2) Supraventricular tachycardia
2. Between 22 and 37 weeks’ gestation
3. Singleton pregnancy
4. Written consent for participation in the clinical trial obtained from the patient herself
What is the exclusion criteria of this trial?+ SHOW
1. Concomitant psychological disorder
2. Implementation of fetal therapy may place the mother at severe risk (drugs to control arrhythmia, etc., cannot be used)
3. Any cases considered inappropriate by the leading physician (concomitant abnormalities in the fetus, etc.)
Flow of this clinical trials?+ SHOW
Drugs that control arrhythmia are administered to the mother, in line with the “Protocol for Clinical Trial Therapies,” to stop arrhythmia in the fetus. If the fetal heart beat either recovers to normal, or falls to 180bpm or below, the pregnancy can be continued and delivery in an improved condition becomes possible. The observation must be taken to ensure arrhythmia does not recur subsequent to birth, so the infants in the trial are monitored until their third birthday 3 yrs old. The carful observation is required with regard to side effects on the mother. In this clinical trial, the Safety Monitoring Committee (which comprises a range of specialists from different areas) meets periodically in order to maintain safety levels.
The period of this clinical research and target number of cases?+ SHOW
Period of research: October 2010 to December 2019
Target number of cases: 50
Registration preriod: December 2015
Which institutions are implementing the clinical trial?+ SHOW
At May 31st, 2013, the following institutions were able to register cases to the trial (listed in order of registration):
We are currently in the process of extending the number of institutions involved in this research.
• National Cerebral and Cardiovascular Center <Data center for this Clinical Trial>
• Kurume University School of Medicine
• Osaka Medical Center and Research Institute for Maternal and Child Health
• National Center for Child Health and Development
• Kanagawa Children’s Medical Center
• University of Tsukuba
• Toho University Omori Medical Center
• Hokkaido University
• Hyogo prefectural Kobe Children’s Hospital
*Case registration requires the approval of the Ethics Committee and Advanced Medical Technology Center.
Takekazu Miyoshi, M.D.
Department of Perinatology and Gynecology, National Cerebral and Cardiovascular Center
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
E-mail address: email@example.com