Children Clinical Trial
Official title:
Pilot Trial: the Safety and Feasibility of Losartan Therapy for Treatment of Pulmonary Vein Stenosis in Pediatric Patients
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with
pulmonary vein stenosis.
It is an open label single arm interventional study. The patient population involves
pediatric patients with stenosis in 2 or more pulmonary veins. Patients will be given
losartan for 1 year. Outcomes include measures of safety/adverse events and progression of
pulmonary vein stenosis.
This pilot study evaluates the safety and feasibility of losartan in pediatric patients with
pulmonary vein stenosis.
Large animal studies have demonstrated that losartan can ameliorate the progression of
pulmonary vein stenosis in a surgical model of pulmonary vein stenosis.
There is no safety data for losartan in children < 6months of age or in children with
pulmonary vein stenosis. Therefore, this study will test the safety and feasibility of
losartan in children in an open label single arm interventional study.
Patient inclusion criteria includes stenosis involving 2 or more pulmonary veins. Patients
who are consented into the trial with be on losartan therapy for one year. They will undergo
study visits every 3 months. Patients will be screened for adverse events through biochemical
tests, routine clinical tests and questionnaires.
An exploratory efficacy analysis will compare progression of pulmonary vein stenosis in
children enrolled in losartan to a contemporary cohort of children with pulmonary vein
stenosis, who did not receive losartan.
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