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

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).

Conditions

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

Interventions

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)

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Edgar Jaeggi

  lead OTHER

Principal Investigators

• Edgar Jaeggi, MD · The Hospital for Sick Children, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2024-03-31

Completion

2024-03-31

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Germany
• Netherlands
• United Kingdom

Study Locations