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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02624765




Registration number
NCT02624765
Ethics application status
Date submitted
30/11/2015
Date registered
8/12/2015

Titles & IDs
Public title
Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)
Scientific title
FAST RCT: Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy
Secondary ID [1] 0 0
1000039945
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal Atrial Flutter Without Hydrops 0 0
Fetal Supraventricular Tachycardia Without Hydrops 0 0
Fetal Supraventricular Tachycardia With Hydrops 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Digoxin (monotherapy)
Treatment: Drugs - Sotalol (monotherapy)
Treatment: Drugs - Flecainide (monotherapy)
Treatment: Drugs - Digoxin (dual therapy)
Treatment: Drugs - Sotalol (dual therapy)
Treatment: Drugs - Flecainide (dual therapy)

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.


Treatment: Drugs: 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

Treatment: Drugs: Sotalol (monotherapy)
Oral dose: 80 mg TID or 120 mg BID (240 mg/day)

Treatment: Drugs: Flecainide (monotherapy)
Oral dose: 100 mg TID (300 mg/day)

Treatment: Drugs: 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

Treatment: Drugs: Sotalol (dual therapy)
Oral dose: 160 mg BID (320 mg/day)

Treatment: Drugs: Flecainide (dual therapy)
Oral dose:100 mg TID (300 mg/day)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Timepoint [1] 0 0
Term: 37 0/7 to 41 6/7 weeks
Secondary outcome [1] 0 0
Proportion of patients with cardioversion over time
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Proportion of participants with treatment failure
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Proportion of participants with arrhythmia-related death
Timepoint [3] 0 0
From date of randomization to 30 days of life
Secondary outcome [4] 0 0
Average gestational age at birth
Timepoint [4] 0 0
At birth
Secondary outcome [5] 0 0
Birth weight z-scores
Timepoint [5] 0 0
At birth
Secondary outcome [6] 0 0
Total days of treatment related maternal and neonatal hospitalizations
Timepoint [6] 0 0
From date of randomization to 30 days of life
Secondary outcome [7] 0 0
Maternal prevalence of adverse events and outcome
Timepoint [7] 0 0
From date of randomization to 30 days of life

Eligibility
Key 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
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2024
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
West Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Germany
State/province [15] 0 0
Bonn
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Netherlands
State/province [17] 0 0
Leiden
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Edgar Jaeggi
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edgar Jaeggi, MD
Address 0 0
The Hospital for Sick Children, Toronto
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not planned


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02624765