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

Who is this study for? Child to adult female patients with Fetal Supraventricular Tachycardia
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: No
View:

• Mother has provided written informed consent to participate

• Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops

• Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:

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

• 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)

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

• Untreated tachycardia at time of enrollment

• Singleton Pregnancy

• 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 branch block allowed)

• Resting heart rate ≥ 50 bpm

• Systolic BP ≥ 85 bpm

Locations
United States
California
UCSF Benioff Children's Hospital
Recruiting
San Francisco
Colorado
Children's Hospital of Colorado
Recruiting
Aurora
Washington, D.c.
Children's National Health System
Not yet recruiting
Washington
New York
Cohen Children's Medical Center
Recruiting
New York
Morgan Stanley Children's Hospital of New York-Presbyterian
Recruiting
New York
Ohio
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Tennessee
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Pediatrix Medical Services, Inc,
Recruiting
Austin
Baylor College of Medicine
Recruiting
Houston
Utah
University of Utah
Recruiting
Salt Lake City
Virginia
Children's Hospital of Richmond at VCU
Not yet recruiting
Richmond
Wisconsin
Children's Hospital of Wisconsin
Recruiting
Milwaukee
West Virginia
West Virginia University Research Corporation
Recruiting
Morgantown
Other Locations
Australia
The Royal Women's Hospital
Recruiting
Melbourne
Perth Children's Hospital
Not yet recruiting
Nedlands
Queensland Children's Hospital
Not yet recruiting
South Brisbane
Canada
University of Alberta/WCCHN
Recruiting
Edmonton
CHU Sainte-Justine Hospital
Recruiting
Montreal
Mount Sinai Hospital
Recruiting
Toronto
The Hospital for Sick Children
Recruiting
Toronto
British Columbia Children's Hospital
Recruiting
Vancouver
Germany
UKB Universitätsklinikum BONN
Recruiting
Bonn
Netherlands
Academic Medical Center - AMC
Not yet recruiting
Amsterdam
Leiden University Medical Center - LUMC
Recruiting
Leiden
Erasmus University Medical Center
Not yet recruiting
Rotterdam
University Medical Center Utrecht
Not yet recruiting
Utrecht
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Active, not recruiting
Birmingham
Chelsea and Westminster Hospital NHS Foundation Trust
Active, not recruiting
London
St George's University Hospital Foundation Trust
Active, not recruiting
London
Contact Information
Primary
Prachi Sharma, MSc, CCRA
fast.trial@sickkids.ca
1-416-813-7654
Backup
Diana Balmer-Minnes, H.BSc CCRP
fast.trial@sickkids.ca
1-416-813-7654
Time Frame
Start Date: February 2016
Estimated Completion Date: March 31, 2023
Participants
Target number of participants: 600
Treatments
Active Comparator: RCT A (1st arm): AF without hydrops
Atrial Flutter (AF) without hydrops: Treatment with Digoxin as monotherapy.
Active Comparator: RCT A (2nd arm): AF without hydrops
Atrial Flutter (AF) without hydrops: Treatment with Sotalol as monotherapy.
Active Comparator: RCT B (1st arm): SVT without hydrops
Supraventricular Tachycardia (SVT) without hydrops: Treatment with Digoxin as monotherapy.
Active Comparator: RCT B (2nd arm): SVT without hydrops
Supraventricular Tachycardia (SVT) without hydrops: Treatment with Flecainide as monotherapy.
Active Comparator: RCT C (1st arm): SVT with hydrops
Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Sotalol.
Active Comparator: RCT C (2nd arm): SVT with hydrops
Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Flecainide.
Authors
Umber Argawal, I Beijnum, TJ Steenhuis, Shreeya Moodley, Phil Saul, Nelangi Pinto, Stephanie Levasseur, Stacy Killen, Mark Alexander, Janette Strasburger, Lisa Hornberger, Nancy Ayres, Elizabeth Mitchell, Bettina Cuneo, Allison Divanovic, Nicole Cain, Mary Donofrio, John R Phillips, Anita Moon-Grady, Shreya Moodley, Erika Peterson, Jeannine Schuman-McCoy, Dr. Ben Auld, Janet Brennand, Julene Carvalho, Ulrike Herberg, Mark Kilby, Ulrich Gembruch, Margarita Bartsota, Dr Deane Yim, Christopher Mercer, Darren Hutchinson, Marie-Josee Raboisson, Frank Casey, Greg Ryan, Edgar Jaeggi, Shaine Morris, Nico Blom
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), St George's, University of London
Leads: Edgar Jaeggi

This content was sourced from clinicaltrials.gov

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