Trial document




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  DRKS00016915

Trial Description

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Title

Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial

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Trial Acronym

FAST

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URL of the Trial

http://FastTherapyTrial.com

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Brief Summary in Lay Language

The purpose of this study is to compare the results of two commonly used treatments for unborn babies with atrial flutter or with supraventricular tachycardia. The medications digoxin, sotalol or flecainide are used alone or in combination to treat these two conditions. If hydrops is present treatment is started with two medications to improve the chances of successful treatment.

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Brief Summary in Scientific Language

Three prospective RCT sub-studies to determine the efficacy and safety of specific transplacental drug regimens in suppressing fetal AF without hydrops, SVT without hydrops, and SVT with hydrops.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00016915
  •   2019/04/17
  •   2015/12/18
  •   yes
  •   Approved
  •   265/18-AMG-ff-monozentrisch, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  •   2015-005743-14 
  •   NCT02624765  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   fetal atrial flutter, fetal supraventricular tachycardia, fetal hydrops
  •   I48 -  Atrial fibrillation and flutter
  •   I47 -  Paroxysmal tachycardia
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Interventions/Observational Groups

  •   RCT A - AF WITHOUT HYDROPS: DIGOXIN vs. SOTALOL
    ARM 1: DIGOXIN:
    Aim: therapeutic maternal trough level of 1.0-2.0 ng/ml
    ARM 2: SOTALOL:
    oral Sotalol 80 mg TID or 120 mg BID (240 mg/day)
  •   RCT B - SVT WITHOUT HYDROPS: DIGOXIN vs. FLECAINIDE.
    ARM 1: DIGOXIN:
    Aim: therapeutic maternal trough level of 1.0-2.0 ng/ml
    ARM 2: FLECAINIDE:
    Aim (if available): therapeutic maternal drug level of 0.2-1 µg/ml
    Oral 100 mg TID (300 mg/day)
  •   RCT C - SVT WITH HYDROPS: DIGOXIN PLUS FLECAINIDE vs. DIGOXIN PLUS SOTALOL.
    ARM 1 DIGOXIN plus FLECAINIDE
    DIGOXIN:
    Aim: therapeutic maternal trough level of 1.5-2.0 ng/ml. oral Flecainide 100 mg TID (300 mg/day)
    ARM 2: DIGOXIN PLUS SOTALOL:
    DIGOXIN
    Aim: therapeutic maternal trough level of 1.5-2.0 ng/ml. oral Sotalol 160 mg BID (320 mg/day)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   Yes
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Primary Outcome

proportion of term deliveries of live-born children with a normal cardiac rhythm. Term delivery is defined as birth 37 0/7 weeks gestation or later

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Secondary Outcome

•Proportion of participants with cardioversion over time.
•Proportion of participants with treatment failure:
oNumber of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following:
- cross-over to another drug
- SVT/AF that persists to birth
- preterm birth
- death
•Cause of death (prenatal, postnatal) Proportion of participants (infants) with arrhythmia related death
•Average gestational age at birth
•Birth weight (z-scores)
•Average days of maternal and neonatal hospitalization related to SVA therapy
•Maternal prevalence of pregnancy/treatment-related AEs and outcomes Proportion of AEs / adverse outcomes (prenatal, postnatal)

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Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   United States
  •   Australia
  •   Netherlands
  •   Canada
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/01/29
  •   600
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

•Mother has provided written informed consent to participate in the RCT
•Mother aged ≥18 years at time of enrolment
•Fetal AF without hydrops (RCT A) or SVT without hydrops (RCT B) or SVT with hydrops (RCT C)
•Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
- Tachycardia ≥ 170 bpm during +100% of time (≤ 30 0/7 weeks of gestation)
- Tachycardia ≥ 180 bpm during at least 10% of observation time
- Tachycardia ≥ 280 bpm
- Tachycardia with fetal hydrops
•Gestational age ≥ 12 0/7 weeks and <36 0/7 weeks at time of enrolment
•Untreated arrhythmia at time of enrolment
•Singleton Pregnancy
•Healthy mother with ± normal pre-treatment cardiovascular findings:
- ECG within normal range (sinus rhythm; QTc ≤ 0.47; PR ≤ 0.2 sec; QRS: ≤ 0.12 sec; insignificant anomalies isolated premature beats; isolated complete right bundle branch block;non-specific ST-T segment changes allowed)
- Maternal resting heart rate ≥ 50 bpm
- Maternal Systolic BP ≥ 85 mm Hg

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Exclusion Criteria

•Fetal AF with hydrops (condition is too infrequent to be studied in a separate RCT sub-study; eligible for Registry)
•Any maternal-fetal conditions associated with high odds of premature delivery and/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)
•History of significant maternal obstructive airway disease including asthma
•Maternal serum potassium level < 3.3mmol/L / <3.3 mEq/L
•Maternal ionized serum calcium level of <1 mmol/L / <4mg/dL or total serum calcium level <2mmol/L / < 8mg/dL
•Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)
•Maternal intake of QT-prolonging medication including but not limited to the following medications: http://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf

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Addresses

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    • The Hospital for Sick Children
    • Mr.  Dr.  Edgar  Jaeggi 
    • M5G 1X8  Toronto
    • Canada
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    • Universitätsklinikum BonnRheinische Friedrich - Wilhelm - UniversitätZentrum für KinderheilkundeAbteilung für Kinderkardiologie
    • Ms.  PD Dr. med.  Ulrike  Herberg 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum BonnRheinische Friedrich - Wilhelm - UniversitätZentrum für KinderheilkundeAbteilung für Kinderkardiologie
    • Ms.  PD Dr. med.  Ulrike  Herberg 
    • Sigmund-Freud-Str. 25
    • 53129  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Canadian Institute of Health Research (CIHR)
    • 160 Elgin Street
    • K1A 0W9  Ottawa
    • Canada
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.