Theophylline Effects in the Fontan Circulation (NCT05717049) | Clinical Trial Compass
CompletedPhase 2
Theophylline Effects in the Fontan Circulation
Norway10 participantsStarted 2023-02-09
Plain-language 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.
Who can participate
Age range16 Years – 25 Years
SexALL
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Inclusion criteria
✓. Participants with univentricular congenital heart disease with a Fontan-type palliation
✓. Who are able to perform all diagnostic and monitoring procedures necessary during trial period, in particular being able to perform a symptom-limited cardiopulmonary exercise test on an upright ergometer bicycle.
✓. With available hepatic imaging results (ultrasound or magnetic resonance imaging) from less than 12 months before inclusion
Exclusion criteria
✕. Considered and assessed eligible for administration of Theo-Dur® (theophylline) as specified in the SmPC.
✕. Body mass index (BMI) within the range 18.5 - 34.9 kg/m2 (inclusive).
✕. Contraceptive use by women is not under any national / local regulations in Norway.
✕. Male participants: no restrictions.
✕. Female participants: female participants should have a negative pregnancy test at inclusion and they receive information prior to consent that onset of pregnancy during treatment period has to be reported to the study team and leads to exclusion.
✕. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
✕. Current or previous (last 12 months) tachyarrhythmia which has been cause of medical investigation or hospitalization.