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

PHASE3CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

March 31, 2024

Study Completion Date

March 31, 2024

Conditions
Fetal Atrial Flutter Without HydropsFetal Supraventricular Tachycardia Without HydropsFetal Supraventricular Tachycardia With Hydrops
Interventions
DRUG

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

DRUG

Sotalol (monotherapy)

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

DRUG

Flecainide (monotherapy)

Oral dose: 100 mg TID (300 mg/day)

DRUG

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

DRUG

Sotalol (dual therapy)

Oral dose: 160 mg BID (320 mg/day)

DRUG

Flecainide (dual therapy)

Oral dose:100 mg TID (300 mg/day)

Trial Locations (22)

10032

Morgan Stanley Children's Hospital of New York-Presbyterian, New York

20010

Children's National Health System, Washington D.C.

26506

West Virginia University Research Corporation, Morgantown

37232

Vanderbilt University Medical Center, Nashville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

53226

Children's Hospital of Wisconsin, Milwaukee

77030

Baylor College of Medicine, Houston

78722

Pediatrix Medical Services, Inc,, Austin

80045

Children's Hospital of Colorado, Aurora

84112

University of Utah, Salt Lake City

94158

UCSF Benioff Children's Hospital, San Francisco

269-01

Cohen Children's Medical Center, New York

Unknown

The Royal Women's Hospital, Melbourne

University of Alberta/WCCHN, Edmonton

Mount Sinai Hospital, Toronto

The Hospital for Sick Children, Toronto

CHU Sainte-Justine Hospital, Montreal

UKB Universitätsklinikum BONN, Bonn

Academic Medical Center - AMC, Amsterdam

Leiden University Medical Center - LUMC, Leiden

St George's University Hospital Foundation Trust, London

V6H 3N1

British Columbia Children's Hospital, Vancouver

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Edgar Jaeggi

OTHER

NCT02624765 - Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT) | Biotech Hunter | Biotech Hunter