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

Last updated: May 21, 2024
Sponsor: Edgar Jaeggi
Overall Status: Completed

Phase

3

Condition

Fast Heart Rate (Tachycardia)

Atrial Flutter

Atrial Fibrillation

Treatment

Flecainide (dual therapy)

Digoxin (dual therapy)

Digoxin (monotherapy)

Clinical Study ID

NCT02624765
1000039945
  • Ages 16-50
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Mother has provided written informed consent to participate

  2. Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops

  3. Tachyarrhythmia that is significant enough to justify immediate transplacentalpharmacological treatment:

  • Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes orlonger

  • Tachycardia ≥ 170 bpm during +100% of time (≤ 30 0/7 weeks of gestation)

  • Tachycardia ≥ 280 bpm (irrespective of SVA duration)

  • SVT with fetal hydrops (irrespective of duration)

  1. Gestational age > 12 0/7 weeks and <36 0/7 weeks at time of enrollment

  2. Untreated tachycardia at time of enrollment

  3. Singleton Pregnancy

  4. Healthy mother with ± normal pre-treatment cardiovascular findings:

  • ECG without significant abnormalities (sinus rhythm; QTc ≤ 0.47; PR ≤ 0.2 sec;QRS: ≤ 0.12 sec; isolated PACs or PVCs or isolated complete right bundle branchblock allowed)

  • Resting heart rate ≥ 50 bpm

  • Systolic BP ≥ 85 bpm

Exclusion

Exclusion Criteria:

  1. AF with hydrops (eligible for FAST Registry only)

  2. Any maternal-fetal conditions associated with high odds of premature delivery ordeath other than tachycardia (e.g. severe IUGR; premature rupture of membrane;life-threatening maternal disease (incl. pre-eclampsia; HELLP syndrome); severecongenital fetal abnormalities (T 13 or 18; surgery or death expected < 1 month)

  3. History of significant maternal heart condition (open heart surgery; sick sinussyndrome; channelopathy (long QT, Brugada syndrome); ventricular tachycardia; WPWsyndrome; high-degree heart block; cardiomyopathy)

  4. Relevant preexisting maternal obstructive airway disease including asthma

  5. Current therapy with the following medications:

  • Antiarrhythmic drugs

  • Pentamidine

  1. Maternal serum potassium level <3.3 mmol/L / <3.3 mEq/L (at start of treatment)

  2. Maternal ionized serum calcium level of <1 mmol/L / <4 mg/dL) or total serum calciumlevel <2 mmol/L / <8mg/dL (at start of treatment)

  3. Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)

Study Design

Total Participants: 105
Treatment Group(s): 6
Primary Treatment: Flecainide (dual therapy)
Phase: 3
Study Start date:
February 01, 2016
Estimated Completion Date:
March 31, 2024

Study 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).

Connect with a study center

  • Queensland Children's Hospital

    South Brisbane, Queensland QLD 4101
    Australia

    Site Not Available

  • The Royal Women's Hospital

    Melbourne, Victoria
    Australia

    Site Not Available

  • Perth Children's Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • University of Alberta/WCCHN

    Edmonton, Alberta
    Canada

    Site Not Available

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario
    Canada

    Site Not Available

  • CHU Sainte-Justine Hospital

    Montreal, Quebec
    Canada

    Site Not Available

  • Alberta Children's Hospital

    Calgary,
    Canada

    Site Not Available

  • McMaster University

    Hamilton,
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa,
    Canada

    Site Not Available

  • UKB Universitätsklinikum BONN

    Bonn,
    Germany

    Site Not Available

  • Academic Medical Center - AMC

    Amsterdam,
    Netherlands

    Site Not Available

  • Leiden University Medical Center - LUMC

    Leiden,
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • University Medical Center Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • Belfast Health and Social Care Trust

    Belfast,
    United Kingdom

    Site Not Available

  • Belfast Health and Social Care Trust

    Belfast, Northern Ireland,
    United Kingdom

    Site Not Available

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham,
    United Kingdom

    Site Not Available

  • University Hospital Bristol

    Bristol,
    United Kingdom

    Site Not Available

  • The Ian Donald Centre for Foetal Medicine, Southern General Hospital

    Glasgow,
    United Kingdom

    Site Not Available

  • Liverpool Women's Hospital

    Liverpool,
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • St George's University Hospital Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • University Hospital Southampton

    Southampton,
    United Kingdom

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital

    San Francisco, California 94158
    United States

    Site Not Available

  • Children's Hospital of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's Hospital of Colorado

    Denver, Colorado
    United States

    Site Not Available

  • Children's National Health System

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Boston Childrens Hospital

    Boston, Massachusetts
    United States

    Site Not Available

  • Cohen Children's Medical Center

    New York, New York 269-01
    United States

    Site Not Available

  • Morgan Stanley Children's Hospital of New York-Presbyterian

    New York, New York 10032
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • MUSC Children's Hospital

    Charleston, South Carolina
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Pediatrix Medical Services, Inc,

    Austin, Texas 78722
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Children's Hospital of Richmond at VCU

    Richmond, Virginia 23298-0026
    United States

    Site Not Available

  • West Virginia University Research Corporation

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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