The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that examines the efficacy and safety of standard prenatal antiarrhythmic treatment. Study components of FAST include three prospective sub-studies to determine the efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF without hydrops (Randomized Clinical Trial (RCT) A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs are open label phase III trials of standard 1st line therapy, which either is started as monotherapy (no hydrops) or as dual therapy (hydrops).
Few studies are specifically designed to address health concerns relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally fast heart rate up to 300 beats per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus). Although fetal SVA, including atrial flutter (AF) and other forms of supraventricular tachycardia (SVT), is the most common cause of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled trial (RCT). As a consequence, physicians need to make decisions about the management of such pregnancies without any evidence from controlled trials on drug efficacy and safety and no consensus among specialists for the optimal management. The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that addresses this knowledge gap to guide future fetal SVA therapy to the best of care. Study components of FAST include three prospective sub-studies to determine the efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF without hydrops (RCT A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs are open label phase III trials of standard 1st line therapy, which either is started as monotherapy (no hydrops) or as dual therapy (hydrops). The primary study aim is the probability of a normal pregnancy outcome after treatment start with Digoxin or Sotalol (AF without hydrops); Digoxin or Flecainide (SVT without hydrops); and Digoxin plus Sotalol or Digoxin plus Flecainide (SVT with hydrops).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Oral or IV loading dose: 0.5 mg q 12 h (total 4 doses over 48 hours) followed by Oral maintenance dose: 0.25 mg-1mg/day
Oral dose: 80 mg TID or 120 mg BID (240 mg/day)
Oral dose: 100 mg TID (300 mg/day)
Oral or IV loading dose: 0.5 mg q 8 h (total 4 doses over 32 hours) followed by oral maintenance dose: 0.25 mg-1mg/day
Oral dose: 160 mg BID (320 mg/day)
Oral dose:100 mg TID (300 mg/day)
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Children's National Health System
Washington D.C., District of Columbia, United States
Morgan Stanley Children's Hospital of New York-Presbyterian
New York, New York, United States
Cohen Children's Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Pediatrix Medical Services, Inc,
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
...and 12 more locations
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Term delivery (≥37 0/7 weeks gestation) with a normal cardiac rhythm (ECG).
Time frame: Term: 37 0/7 to 41 6/7 weeks
Proportion of patients with cardioversion over time
Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
Time frame: From date of randomization until the date of first documented cardioversion or until the date of delivery/fetal death without cardioversion, whichever comes first, assessed up to 30 gestational weeks
Proportion of participants with treatment failure
Number of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following: 1) cross-over to another drug; 2) SVT/AF that persists to birth; 3) preterm birth; 4) death.
Time frame: From date of randomization until the date of first documented fetal cardioversion or until the date of treatment failure, whichever comes first, assessed up to 30 gestational weeks
Proportion of participants with arrhythmia-related death
Number of participants with arrhythmia-related death compared to other outcomes
Time frame: From date of randomization to 30 days of life
Average gestational age at birth
Mean of the gestational age at birth
Time frame: At birth
Birth weight z-scores
A birth weight z-score compares a child's birth weight to the weight of a child of the same length/height and gender to classify nutritional status
Time frame: At birth
Total days of treatment related maternal and neonatal hospitalizations
Average days of maternal and neonatal hospitalization related to SVA therapy
Time frame: From date of randomization to 30 days of life
Maternal prevalence of adverse events and outcome
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Time frame: From date of randomization to 30 days of life
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