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Cardiac drug

RCT A (1st arm): AF without hydrops for Fetal Atrial Flutter

Q: What is the most common condition that RCT C (2nd arm): SVT with hydrops is used to treat?

RCT C (2nd arm): SVT with hydrops is the standard of care for severe paroxysmal <a href="https://www.withpower.com/clinical-trials/atrial-fibrillation">atrial fibrillation</a>. This treatment option is also frequently used to manage myocardial contractility, paroxysmal supraventricular tachycardia, and cardiac arrhythmia.

Q: For which patients does this research project seek participants?

This trial is looking for 600 individuals that have supraventricular tachycardia and are aged 16-50. Other inclusion criteria are as follows: Must not have received any treatment for their tachycardia, ECG must be without significant abnormalities, must have a gestational age between 12-36 weeks, tachycardia must be ≥170 bpm for 100% of time, tachycardia must be ≥280 bpm at any time, tachycardia must be ≥180 bpm during at least 10% of observation time, mother must provide written consent to participate.

Q: Are there any dangers associated with RCT C (2nd arm): SVT with hydrops for patients?

Because this is a phase 3 trial, there is available data that supports the efficacy and safety of RCT C (2nd arm): SVT with hydrops, and so our team has given it a score of 3.

Q: Are there a few research centers conducting this trial throughout America?

Currently, there are 18 different sites where this trial is taking place. If you enroll, try and select a location that is close to you to avoid having to travel long distances. The locations are situated in San Francisco, Toronto, Milwaukee and other cities.

Q: Does this test only allow for volunteers who are 30 years or younger?

The parameters for age eligibility for this study are 16 to 50 years old.

Q: Are there precedents for using RCT C (2nd arm): SVT with hydrops in a clinical setting?

As of the current moment, 19 different clinical trials are underway to research RCT C (2nd arm): SVT with hydrops. Two of those trials have reached Phase 3. The majority of the investigations for RCT C (2nd arm): SVT with hydrops are taking place in Nedlands, Western Australia, but there are a total of 120 research sites for this particular treatment.

Q: Are we still able to enroll new test subjects for this experiment?

Yes, this is an ongoing trial that is actively recruiting patients, as denoted by the clinicaltrials.gov website. This specific trial was first posted on February 1st, 2016 and was last updated on October 12th, 2021. The trial has 18 different sites and is looking to enroll 600 individuals in total.

Phase 3

Waitlist Available

Led By Edgar Jaeggi, MD

Research Sponsored by Edgar Jaeggi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gestational age > 12 0/7 weeks and <36 0/7 weeks at time of enrollment

Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization to 30 days of life

Awards & highlights

Study Summary

This trial is designed to study the efficacy and safety of commonly used transplacental drug regimens in suppressing fetal atrial flutter or supraventricular tachycardia, which can cause an abnormally fast heart rate in the fetus.

Who is the study for?

This trial is for pregnant women over 12 weeks gestation with a healthy heart rate and blood pressure, carrying a single baby experiencing rapid heartbeat conditions like atrial flutter or supraventricular tachycardia. It's not for those with severe maternal-fetal risks, significant heart conditions, certain electrolyte imbalances, or on specific medications.Check my eligibility

What is being tested?

The FAST RCT evaluates the effectiveness of antiarrhythmic drugs (Digoxin, Sotalol, Flecainide) given through the placenta to treat fetal rapid heartbeat issues. The study has three parts based on whether there's swelling (hydrops) and tests monotherapy versus dual therapy treatments.See study design

What are the potential side effects?

Possible side effects from Digoxin include nausea and irregular heartbeats; Sotalol may cause fatigue and breathlessness; Flecainide can lead to dizziness and visual disturbances. Dual therapies might increase these risks or introduce new ones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 13 and 36 weeks pregnant.

Select...

My condition involves abnormal fetal heart rhythm without severe complications.

Select...

My heart beats irregularly and needs medication treatment before birth.

Select...

My condition involves abnormal fetal heart rhythm without severe complications.

Select...

My baby has swelling due to abnormal heart rhythm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ term: 37 0/7 to 41 6/7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~term: 37 0/7 to 41 6/7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and term: 37 0/7 to 41 6/7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of live-born children with a delivery at term and a normal cardiac rhythm

Secondary outcome measures

Average gestational age at birth

Birth weight z-scores

Maternal prevalence of adverse events and outcome

+4 more

Trial Design

6Treatment groups

Active Control

Group I: RCT A (1st arm): AF without hydropsActive Control1 Intervention

Atrial Flutter (AF) without hydrops: Treatment with Digoxin as monotherapy.

Group II: RCT A (2nd arm): AF without hydropsActive Control1 Intervention

Atrial Flutter (AF) without hydrops: Treatment with Sotalol as monotherapy.

Group III: RCT B (2nd arm): SVT without hydropsActive Control1 Intervention

Supraventricular Tachycardia (SVT) without hydrops: Treatment with Flecainide as monotherapy.

Group IV: RCT C (1st arm): SVT with hydropsActive Control2 Interventions

Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Sotalol.

Group V: RCT C (2nd arm): SVT with hydropsActive Control2 Interventions

Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Flecainide.

Group VI: RCT B (1st arm): SVT without hydropsActive Control1 Intervention

Supraventricular Tachycardia (SVT) without hydrops: Treatment with Digoxin as monotherapy.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edgar JaeggiLead Sponsor

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,344 Previous Clinical Trials

26,453,312 Total Patients Enrolled

St George's, University of LondonOTHER

131 Previous Clinical Trials

95,181 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most common condition that RCT C (2nd arm): SVT with hydrops is used to treat?

"RCT C (2nd arm): SVT with hydrops is the standard of care for severe paroxysmal atrial fibrillation. This treatment option is also frequently used to manage myocardial contractility, paroxysmal supraventricular tachycardia, and cardiac arrhythmia."

Answered by AI

For which patients does this research project seek participants?

"This trial is looking for 600 individuals that have supraventricular tachycardia and are aged 16-50. Other inclusion criteria are as follows: Must not have received any treatment for their tachycardia, ECG must be without significant abnormalities, must have a gestational age between 12-36 weeks, tachycardia must be ≥170 bpm for 100% of time, tachycardia must be ≥280 bpm at any time, tachycardia must be ≥180 bpm during at least 10% of observation time, mother must provide written consent to participate."

Answered by AI

Are there any dangers associated with RCT C (2nd arm): SVT with hydrops for patients?

"Because this is a phase 3 trial, there is available data that supports the efficacy and safety of RCT C (2nd arm): SVT with hydrops, and so our team has given it a score of 3."

Answered by AI

Are there a few research centers conducting this trial throughout America?

"Currently, there are 18 different sites where this trial is taking place. If you enroll, try and select a location that is close to you to avoid having to travel long distances. The locations are situated in San Francisco, Toronto, Milwaukee and other cities."

Answered by AI

Does this test only allow for volunteers who are 30 years or younger?

"The parameters for age eligibility for this study are 16 to 50 years old."

Answered by AI

Are there precedents for using RCT C (2nd arm): SVT with hydrops in a clinical setting?

"As of the current moment, 19 different clinical trials are underway to research RCT C (2nd arm): SVT with hydrops. Two of those trials have reached Phase 3. The majority of the investigations for RCT C (2nd arm): SVT with hydrops are taking place in Nedlands, Western Australia, but there are a total of 120 research sites for this particular treatment."

Answered by AI

Are we still able to enroll new test subjects for this experiment?

"Yes, this is an ongoing trial that is actively recruiting patients, as denoted by the clinicaltrials.gov website. This specific trial was first posted on February 1st, 2016 and was last updated on October 12th, 2021. The trial has 18 different sites and is looking to enroll 600 individuals in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Edgar Jaeggi 2016. "Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02624765.

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