drugset / Trial / NCT02624765
Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2016-02
- Primary completion
- 2024-03-31
- Completion
- 2024-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Comparator | Digoxin | Other / unclassified | 1 mg | Oral |
| Comparator | flecainide | Small molecule | 100 mg | Oral |
| Comparator | sotalol | Small molecule | 80 mg | Oral |
| Comparator | sotalol | Small molecule | 120 mg | Oral |
| Comparator | sotalol | Small molecule | 160 mg | Oral |