A single group treatment phase 2 single-arm no-masking study to assess safety and efficacy of
a short-term oral treatment with theophylline (ATC-no. R03D A04) in terms of improvements in
cardiorespiratory fitness, health-related quality of life, cardiac performance and
respiratory function in male and female adolescents aged 16 to 25 years with a Fontan-type
surgical palliation of univentricular congenital heart disease.
Phase:
Phase 2
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Norwegian Association for Children with Congenital Heart Disease Norwegian Health Association South-Eastern Norway Regional Health Authority