Fetal Atrial Flutter Without HydropsPhase 3NCT02624765

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

A Phase 3 study testing Digoxin (monotherapy), Sotalol (monotherapy) and Flecainide (monotherapy) in people with Fetal Atrial Flutter Without Hydrops and Fetal Supraventricular Tachycardia Without Hydrops, run by Edgar Jaeggi at 22 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 50 years, women only
Conditions the study is for: Fetal Atrial Flutter Without Hydrops, Fetal Supraventricular Tachycardia Without Hydrops, Fetal Supraventricular Tachycardia With Hydrops
What is being tested?: Digoxin (monotherapy), Sotalol (monotherapy) and Flecainide (monotherapy)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 22 sitesin 6 countries
Study dates: Feb 2016to 31 Mar 2024
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 50 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

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)

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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

Who cannot join

AF with hydrops (eligible for FAST Registry only)
Any maternal-fetal conditions associated with high odds of premature delivery or death other than tachycardia (e.g. severe IUGR; premature rupture of membrane; life-threatening maternal disease (incl. pre-eclampsia; HELLP syndrome); severe congenital fetal abnormalities (T 13 or 18; surgery or death expected < 1 month)
History of significant maternal heart condition (open heart surgery; sick sinus syndrome; channelopathy (long QT, Brugada syndrome); ventricular tachycardia; WPW syndrome; high-degree heart block; cardiomyopathy)
Relevant preexisting maternal obstructive airway disease including asthma
Current therapy with the following medications:
Antiarrhythmic drugs

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Pentamidine
Maternal serum potassium level <3.3 mmol/L / <3.3 mEq/L (at start of treatment)
Maternal ionized serum calcium level of <1 mmol/L / <4 mg/dL) or total serum calcium level <2 mmol/L / <8mg/dL (at start of treatment)
Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)

Trial locations and contacts

22 sites in 6 countries.

Country

City, postcode or hospital

22 sites in 6 countries

United States12 sites

Children's Hospital of Colorado
Aurora, Colorado, 80045
Pediatrix Medical Services, Inc,
Austin, Texas, 78722
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Baylor College of Medicine
Houston, Texas, 77030
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University Research Corporation
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Morgan Stanley Children's Hospital of New York-Presbyterian
New York, New York, 10032
Cohen Children's Medical Center
New York, New York, 269-01
University of Utah
Salt Lake City, Utah, 84112
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Children's National Health System
Washington D.C., District of Columbia, 20010

Other trials in United States

Canada5 sites

University of Alberta/WCCHN
Edmonton, Alberta
CHU Sainte-Justine Hospital
Montreal, Quebec
Mount Sinai Hospital
Toronto, Ontario
The Hospital for Sick Children
Toronto, Ontario
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1

Other trials in Canada

Netherlands2 sites

Academic Medical Center - AMC
Amsterdam
Leiden University Medical Center - LUMC
Leiden

Other trials in Netherlands

Australia1 site

The Royal Women's Hospital
Melbourne, Victoria

Other trials in Australia

Germany1 site

UKB Universitätsklinikum BONN
Bonn

Other trials in Germany

United Kingdom1 site

St George's University Hospital Foundation Trust
London

Other trials in United Kingdom

About this study

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

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).

Read the 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
Being tested: Digoxin (monotherapy), Sotalol (monotherapy), Flecainide (monotherapy), Digoxin (dual therapy), Sotalol (dual therapy)
Keywords: RCT A: Fetal Atrial Flutter without Hydrops, RCT B: Fetal Supraventricular Tachycardia without Hydrops, RCT C: Fetal Supraventricular Tachycardia with Hydrops

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02624765
Study group	Role	What they receive
RCT A (1st arm): AF without hydrops	Active comparator	Atrial Flutter (AF) without hydrops: Treatment with Digoxin as monotherapy. Receives: Drug: Digoxin (monotherapy)
RCT A (2nd arm): AF without hydrops	Active comparator	Atrial Flutter (AF) without hydrops: Treatment with Sotalol as monotherapy. Receives: Drug: Sotalol (monotherapy)
RCT B (1st arm): SVT without hydrops	Active comparator	Supraventricular Tachycardia (SVT) without hydrops: Treatment with Digoxin as monotherapy. Receives: Drug: Digoxin (monotherapy)
RCT B (2nd arm): SVT without hydrops	Active comparator	Supraventricular Tachycardia (SVT) without hydrops: Treatment with Flecainide as monotherapy. Receives: Drug: Flecainide (monotherapy)
RCT C (1st arm): SVT with hydrops	Active comparator	Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Sotalol. Receives: Drug: Digoxin (dual therapy); Drug: Sotalol (dual therapy)
RCT C (2nd arm): SVT with hydrops	Active comparator	Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Flecainide. Receives: Drug: Digoxin (dual therapy); Drug: Flecainide (dual therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Term delivery (≥37 0/7 weeks gestation) with a normal cardiac rhythm (ECG).
Measured: Term: 37 0/7 to 41 6/7 weeks

Secondary outcomes (7)

Proportion of patients with cardioversion over time
Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
Measured: From date of randomization until the date of first documented cardioversion or until the date of delivery/fetal death without cardioversion, whichever comes first, assessed up to 30 gestational weeks
Proportion of participants with treatment failure
Number of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following: 1) cross-over to another drug; 2) SVT/AF that persists to birth; 3) preterm birth; 4) death.
Measured: From date of randomization until the date of first documented fetal cardioversion or until the date of treatment failure, whichever comes first, assessed up to 30 gestational weeks
Proportion of participants with arrhythmia-related death
Number of participants with arrhythmia-related death compared to other outcomes
Measured: From date of randomization to 30 days of life
Average gestational age at birth
Mean of the gestational age at birth
Measured: At birth
Birth weight z-scores
A birth weight z-score compares a child's birth weight to the weight of a child of the same length/height and gender to classify nutritional status
Measured: At birth
Total days of treatment related maternal and neonatal hospitalizations
Average days of maternal and neonatal hospitalization related to SVA therapy
Measured: From date of randomization to 30 days of life
Maternal prevalence of adverse events and outcome
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Measured: From date of randomization to 30 days of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201631 Mar 2024

First posted8 Dec 2015 (estimated)
Study startFeb 2016
Primary completion31 Mar 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fetal Atrial Flutter Without HydropsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02624765
Sponsor's protocol ID: 1000039945
Status last verified: May 2024
First submitted: 30 Nov 2015
Last updated: 22 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Not planned