Trials Sponsors Conditions Drugs Pricing

Conditions

Fetal Atrial Flutter Without Hydrops Fetal Supraventricular Tachycardia Without Hydrops Fetal Supraventricular Tachycardia With Hydrops

Keywords

RCT A: Fetal Atrial Flutter without HydropsRCT B: Fetal Supraventricular Tachycardia without HydropsRCT C: Fetal Supraventricular Tachycardia with Hydrops

Outcome Measures

Primary Outcomes (1)

Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Term delivery (≥37 0/7 weeks gestation) with a normal cardiac rhythm (ECG).
Term: 37 0/7 to 41 6/7 weeks

Secondary Outcomes (7)

Proportion of patients with cardioversion over time
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
Proportion of participants with treatment failure
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

Study Arms (6)

RCT A (1st arm): AF without hydrops

ACTIVE COMPARATOR

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

Drug: Digoxin (monotherapy)

RCT A (2nd arm): AF without hydrops

ACTIVE COMPARATOR

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

Drug: Sotalol (monotherapy)

RCT B (1st arm): SVT without hydrops

ACTIVE COMPARATOR

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

Interventions

Digoxin (monotherapy)Drug

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

RCT A (1st arm): AF without hydropsRCT B (1st arm): SVT without hydrops

Sotalol (monotherapy)Drug

Oral dose: 80 mg TID or 120 mg BID (240 mg/day)

RCT A (2nd arm): AF without hydrops

Eligibility Criteria

Age16 Years - 50 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Mother has provided written informed consent to participate
Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops

Sponsors & Collaborators

Canadian Institutes of Health Research (CIHR)
Governmentcollaborator
Edgar Jaeggi
Otherlead

Study Sites (22)

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Morgan Stanley Children's Hospital of New York-Presbyterian

New York, New York, 10032, United States

Cohen Children's Medical Center

New York, New York, 269-01, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Vanderbilt University Medical Center

MeSH Terms

Interventions

DigoxinSotalolFlecainide

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesEthanolaminesAmino AlcoholsAlcohols

Study Officials

Edgar Jaeggi, MD
The Hospital for Sick Children, Toronto
PRINCIPAL INVESTIGATOR

Enrollment

105 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Edgar Jaeggi, MD FRCP (C)

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 8, 2015

Study Start

February 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (6)

RCT A (1st arm): AF without hydrops

RCT A (2nd arm): AF without hydrops

RCT B (1st arm): SVT without hydrops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

RCT B (2nd arm): SVT without hydrops

RCT C (1st arm): SVT with hydrops

RCT C (2nd arm): SVT with hydrops

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (6)

RCT A (1st arm): AF without hydrops

RCT A (2nd arm): AF without hydrops

RCT B (1st arm): SVT without hydrops

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

RCT B (2nd arm): SVT without hydrops

RCT C (1st arm): SVT with hydrops

RCT C (2nd arm): SVT with hydrops

You may not qualify if:

Data Sharing

Source record

Documents

Locations