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

1000039945

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).

2016-02-01

2024-03-31

2024-03-31

Completed

Early phase I

105

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

2024-05-22