Fetal Atrial Flutter Without Hydrops Clinical Trial
Official title:
FAST RCT: Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy
| Verified date | January 2024 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that examines the efficacy and safety of standard prenatal antiarrhythmic treatment. Study components of FAST include three prospective sub-studies to determine the efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF without hydrops (Randomized Clinical Trial (RCT) A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs are open label phase III trials of standard 1st line therapy, which either is started as monotherapy (no hydrops) or as dual therapy (hydrops).
| Status | Active, not recruiting |
| Enrollment | 105 |
| Est. completion date | March 31, 2024 |
| Est. primary completion date | March 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 16 Years to 50 Years |
| Eligibility | 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 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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Royal Women's Hospital | Melbourne | Victoria |
| Canada | University of Alberta/WCCHN | Edmonton | Alberta |
| Canada | CHU Sainte-Justine Hospital | Montreal | Quebec |
| Canada | Mount Sinai Hospital | Toronto | Ontario |
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
| Germany | UKB Universitätsklinikum BONN | Bonn | |
| Netherlands | Academic Medical Center - AMC | Amsterdam | |
| Netherlands | Leiden University Medical Center - LUMC | Leiden | |
| United Kingdom | St George's University Hospital Foundation Trust | London | |
| United States | Children's Hospital of Colorado | Aurora | Colorado |
| United States | Pediatrix Medical Services, Inc, | Austin | Texas |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
| United States | West Virginia University Research Corporation | Morgantown | West Virginia |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Cohen Children's Medical Center | New York | New York |
| United States | Morgan Stanley Children's Hospital of New York-Presbyterian | New York | New York |
| United States | University of Utah | Salt Lake City | Utah |
| United States | UCSF Benioff Children's Hospital | San Francisco | California |
| United States | Children's National Health System | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Edgar Jaeggi | Canadian Institutes of Health Research (CIHR) |
United States, Australia, Canada, Germany, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Proportion of patients with cardioversion over time | Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm 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 | |
| Secondary | Proportion of participants with treatment failure | Number of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following: 1) cross-over to another drug; 2) SVT/AF that persists to birth; 3) preterm birth; 4) death. | 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 | Proportion of participants with arrhythmia-related death | Number of participants with arrhythmia-related death compared to other outcomes | From date of randomization to 30 days of life | |
| Secondary | Average gestational age at birth | Mean of the gestational age at birth | At birth | |
| Secondary | Birth weight z-scores | A birth weight z-score compares a child's birth weight to the weight of a child of the same length/height and gender to classify nutritional status | At birth | |
| Secondary | Total days of treatment related maternal and neonatal hospitalizations | Average days of maternal and neonatal hospitalization related to SVA therapy | From date of randomization to 30 days of life | |
| Secondary | Maternal prevalence of adverse events and outcome | Maternal prevalence of pregnancy/treatment-related AEs and outcomes | From date of randomization to 30 days of life |