NCT02624765

Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)

FAST RCT: Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Edgar Jaeggi · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

• Fetal Atrial Flutter Without Hydrops
• Fetal Supraventricular Tachycardia Without Hydrops
• Fetal Supraventricular Tachycardia With Hydrops

Interventions

Type	Name	Description
DRUG	Digoxin (monotherapy)	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
DRUG	Sotalol (monotherapy)	Oral dose: 80 mg TID or 120 mg BID (240 mg/day)
DRUG	Flecainide (monotherapy)	Oral dose: 100 mg TID (300 mg/day)
DRUG	Digoxin (dual therapy)	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
DRUG	Sotalol (dual therapy)	Oral dose: 160 mg BID (320 mg/day)
DRUG	Flecainide (dual therapy)	Oral dose:100 mg TID (300 mg/day)

Timeline

• Start date: 2016-02-01
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2015-12-08
• Last updated: 2024-05-22

Locations

22 sites across 6 countries: United States, Australia, Canada, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study