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

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ClinicalTrials.gov Identifier: NCT02624765
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : October 20, 2021
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
St George's, University of London
Information provided by (Responsible Party):
Edgar Jaeggi, The Hospital for Sick Children

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Fetal Atrial Flutter Without Hydrops Fetal Supraventricular Tachycardia Without Hydrops Fetal Supraventricular Tachycardia With Hydrops Drug: Digoxin (monotherapy) Drug: Sotalol (monotherapy) Drug: Flecainide (monotherapy) Drug: Digoxin (dual therapy) Drug: Sotalol (dual therapy) Drug: Flecainide (dual therapy) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FAST RCT: Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy
Actual Study Start Date : February 2016
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: RCT A (1st arm): AF without hydrops
Atrial Flutter (AF) without hydrops: Treatment with Digoxin as monotherapy.
 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
Active Comparator: RCT A (2nd arm): AF without hydrops
Atrial Flutter (AF) without hydrops: Treatment with Sotalol as monotherapy.
 Drug: Sotalol (monotherapy)
Oral dose: 80 mg TID or 120 mg BID (240 mg/day)
Active Comparator: RCT B (1st arm): SVT without hydrops
Supraventricular Tachycardia (SVT) without hydrops: Treatment with Digoxin as monotherapy.
 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
Active Comparator: RCT B (2nd arm): SVT without hydrops
Supraventricular Tachycardia (SVT) without hydrops: Treatment with Flecainide as monotherapy.
 Drug: Flecainide (monotherapy)
Oral dose: 100 mg TID (300 mg/day)
Active Comparator: RCT C (1st arm): SVT with hydrops
Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Sotalol.
 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)
Active Comparator: RCT C (2nd arm): SVT with hydrops
Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Flecainide.
 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: Flecainide (dual therapy)
Oral dose:100 mg TID (300 mg/day)


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of live-born children with a delivery at term and a normal cardiac rhythm [ Time Frame: Term: 37 0/7 to 41 6/7 weeks ]
    Term delivery (≥37 0/7 weeks gestation) with a normal cardiac rhythm (ECG).


Secondary Outcome Measures :
  1. Proportion of patients with cardioversion over time [ Time Frame: 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 ]
    Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time

  2. Proportion of participants with treatment failure [ Time Frame: 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 ]
    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.

  3. Proportion of participants with arrhythmia-related death [ Time Frame: From date of randomization to 30 days of life ]
    Number of participants with arrhythmia-related death compared to other outcomes

  4. Average gestational age at birth [ Time Frame: At birth ]
    Mean of the gestational age at birth

  5. Birth weight z-scores [ Time Frame: At birth ]
    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

  6. Total days of treatment related maternal and neonatal hospitalizations [ Time Frame: From date of randomization to 30 days of life ]
    Average days of maternal and neonatal hospitalization related to SVA therapy

  7. Maternal prevalence of adverse events and outcome [ Time Frame: From date of randomization to 30 days of life ]
    Maternal prevalence of pregnancy/treatment-related AEs and outcomes


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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)
  4. Gestational age > 12 0/7 weeks and <36 0/7 weeks at time of enrollment
  5. Untreated tachycardia at time of enrollment
  6. Singleton Pregnancy

  7. 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

Exclusion Criteria:

  1. AF with hydrops (eligible for FAST Registry only)
  2. 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)
  3. 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)
  4. Relevant preexisting maternal obstructive airway disease including asthma

  5. Current therapy with the following medications:

    • Antiarrhythmic drugs
    • Pentamidine
  6. Maternal serum potassium level <3.3 mmol/L / <3.3 mEq/L (at start of treatment)
  7. 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)
  8. Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624765


Contacts
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Contact: Prachi Sharma, MSc, CCRA 1-416-813-7654 ext 309423 fast.trial@sickkids.ca
Contact: Diana Balmer-Minnes, H.BSc CCRP 1-416-813-7654 ext 228624 fast.trial@sickkids.ca

Locations
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Sponsors and Collaborators
Edgar Jaeggi
Canadian Institutes of Health Research (CIHR)
St George's, University of London
Investigators
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Principal Investigator: Edgar Jaeggi, MD The Hospital for Sick Children, Toronto
  Study Documents (Full-Text)

Documents provided by Edgar Jaeggi, The Hospital for Sick Children:
Study Protocol and Statistical Analysis Plan  [PDF] July 7, 2017

More Information
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Responsible Party: Edgar Jaeggi, Edgar Jaeggi, MD FRCP (C), Section Head, Fetal Cardiac Program, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02624765    
Other Study ID Numbers: 1000039945
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edgar Jaeggi, The Hospital for Sick Children:
RCT A: Fetal Atrial Flutter without Hydrops
RCT B: Fetal Supraventricular Tachycardia without Hydrops
RCT C: Fetal Supraventricular Tachycardia with Hydrops
Additional relevant MeSH terms:
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Tachycardia
Atrial Flutter
Tachycardia, Supraventricular
Edema
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Digoxin
Sotalol
Flecainide
Anti-Arrhythmia Agents
Cardiotonic Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators