PTN Digoxin Study Reaches Enrollment Goal

The Pediatric Trial Network’s (PTN) Digoxin study recently reached the targeted enrollment goal for its study population of infants with Congenital Heart Disease (CHD). Thanks to the hard work and diligence of the clinical care team part of this study, including the PTN team, the target enrollment goal was timely and successfully met to move forward with collecting data from study participants.

The Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease study is collecting safety and efficacy data on infants with single ventricle CHD to determine the appropriate dosing and safety measures of the study drug digoxin.  Digoxin is approved by the U.S. Food and Drug Administration (FDA) to treat heart failure in patients with congenital heart disease. There has not been enough safety and efficacy data to determine proper dosing of this drug in pediatric patients with single ventricle CHD, which is what the PTN aims to change with this research effort.

Fifty study participants have been recruited for this study, where the drug digoxin is a standard of care protocol to treat heart failure by controlling the functions of the cardiovascular system. Study participants are infants <6 months of age who have single ventricle CHD and who have received an initial surgery to correct it, and whose healthcare team is planning on providing digoxin treatment. Each year about 40,000 infants born in the U.S. are diagnosed with CHD, with single ventricle CHD being the most serious and complex form of the disease.

To review more about the digoxin study, visit ClinicalTrials.gov.

 

 

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