drugset / Trial / NCT05717049
Theophylline Effects in the Fontan Circulation
Phase 2
Completed
10 enrolled
Oslo University Hospital
Norwegian Association for Children with Congenital Heart Disease · collabNorwegian Health Association · collabSouth-Eastern Norway Regional Health Authority · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2023-02-09
- Primary completion
- 2023-09-15
- Completion
- 2023-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Theophylline | Small molecule | 200 mg | Oral |