The FAST Therapy Trial is a prospective trial of patients with a new diagnosis of fetal SVA aimed to compare the impact of different perinatal treatment strategies from the time of SVA diagnosis to birth or death1) The primary outcome will be the…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Foetal complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Term delivery (at least 37 weeks) with a normal cardiac rhythm.
Secondary outcome
*Proportion of patients with cardioversion over time.
* Proportion of patients with treatment failure:
- Fetal demise
- Cross-over to 2nd and/or 3rd line therapy
- Progression to fetal hydrops (SVT or AF/no hydrops)
- Recurrence of SVA on maintenance therapy
- Delivery without SVA termination
*Proportion, timing and cause of death prior to 1 month corrected age.
*Proportion of other events: periventricular leucomalacia and bleeds; NEC;
respiratory distress.
*Average gestational age at birth and birth weight z-scores.
*Average days of maternal and neonatal hospitalization related to SVA therapy.
*Maternal prevalence of pregnancy/treatment-related AEs (including caesarean
section)
Background summary
Pregnancies can be complicated by an abnormally fast heart rate up to 300 beats
per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby
(fetus). This carries significant risks because the baby can tolerate fast
heart rates for only a short period before heart failure, shock or even death
occurs. Premature delivery and perinatal death are frequent adverse outcomes of
babies with heart failure and uncontrolled SVA before birth. Treatment is
offered to most mothers to normalize the fetal heart rate to prevent or treat
fetal heart failure and to continue the pregnancy to term with a normal
delivery. The FAST Therapy Trial aims to determine the efficacy and safety of
standard drug therapy regimens for fetal SVA.
Study objective
The FAST Therapy Trial is a prospective trial of patients with a new diagnosis
of fetal SVA aimed to compare the impact of different perinatal treatment
strategies from the time of SVA diagnosis to birth or death
1) The primary outcome will be the proportion of a term delivery of a live-born
child with a normal cardiac rhythm
2) Secondary outcomes will determine the efficacy of 1st line, 2nd line, and
maintenance drug therapy in controlling the different arrhythmias prior to
birth and patient safety
Study design
This study is an open label Randomized Clinical Trial which compares standard
drug therapies.
Furthermore, there is a Prospective Registry in which patients who are not
randomized for the RCT's, but who have the diagnosis SVA, can be included. In
this line of the trial, patients can be included who do not receive medical
treatment, or who do get therapy but are not eligible for the RCTs within the
FAST therapy trial.
Daarnaast is er een Prospectieve Registry waarin niet gerandomiseerde patiënten
met de diagnose SVA kunnen worden geïncludeerd. In deze tak van de studie
kunnen patiënten worden geïncludeerd die geen therapie krijgen, of die wel
therapie krijgen, maar niet voldoen aan de inclusiecriteria voor de RCT's
binnen de FAST trial.
Intervention
A randomisation of standard medicine protocols are used to treat the AF and
SVT.
Study burden and risks
No extra risk. Additional to the standard medical treatment a questionnaire of
about 5 minutes is completed. .
University Avenue 555
Ontario M5G 1X8
US
University Avenue 555
Ontario M5G 1X8
US
Listed location countries
Age
Inclusion criteria
* Diagnosis: Fetal AF without hydrops or SVT without hydrops or SVT with hydrops.
* Tachyarrhythmia significant enough to justify immediate transplacental pharmacological treatment.
Maternal conditions:
* Gestational age <36 0/7 weeks at time of enrolment.
* Untreated at time of enrolment.
* Singleton pregnancy.
* Healthy mother with normal pre-treatment cardiovascular findings.
* Mother capable to make her own health decisions and to understand and follow medical instruction.
Exclusion criteria
* Fetal AF with hydrops.
* Any maternal-fetal conditions associated with high odds of premature delivery and/or death.
Maternal conditions:
* Any relevant preexisting heart condition.
* Relevant preexisting obstructive airway disease including asthma.
* History of chronic substance abuse.
* Intake of QT-prolonging medication.
* Serum potassium level <3.3 mEq/L.
* Ionized serum calcium level of <1 mmol/l.
* Serum creatinine level >1.1mg/dl.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005743-14-NL |
| ClinicalTrials.gov | NCT02624765 |
| CCMO | NL56803.000.17 |