Univentricular congenital heart disease with a Fontan-type surgical palliation
Conditions
Brief summary
Primary safety endpoints: a. Frequency of treatment emerged AE/SAE b. Freedom from participant dropout based on tolerability of the study intervention c. Number of participants requiring dose reduction after first serum concentration assessment. d. Freedom of arrhythmogenic side effects of the study treatment leading to patient dropout, Difference in oxygen uptake at aerobic threshold pre/post treatment.
Detailed description
Difference in total scores from SF-36 and EQ-5D questionnaires pre/post treatment, Difference in ventricular function as assessed by echocardiography at rest pre/post treatment, Difference in diffusion capacity pre/post treatment, Change in Apnea Hypopnea Index during home-based sleep study pre-/post-treatment
Interventions
DRUGTheo-Dur 200mg depottablett
Sponsors
Oslo University Hospital Hf
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoints: a. Frequency of treatment emerged AE/SAE b. Freedom from participant dropout based on tolerability of the study intervention c. Number of participants requiring dose reduction after first serum concentration assessment. d. Freedom of arrhythmogenic side effects of the study treatment leading to patient dropout, Difference in oxygen uptake at aerobic threshold pre/post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in total scores from SF-36 and EQ-5D questionnaires pre/post treatment, Difference in ventricular function as assessed by echocardiography at rest pre/post treatment, Difference in diffusion capacity pre/post treatment, Change in Apnea Hypopnea Index during home-based sleep study pre-/post-treatment | — |
Countries
Norway
Outcome results
None listed