Clinical TrialID 8462
Theophylline Effects in the Fontan Circulation
NCT05717049
Congenital Heart Disease
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Trial: 1Ingredient: 1Links: 1
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8462
- Evidence Id
- 8462
- Core Evidence Id
- 8462
- Source Clinical Trial Id
- 8460
- Herb2 Clinical Trial Id
- HBCT008460
- Nct Id
- NCT05717049
- Title
- Theophylline Effects in the Fontan Circulation
- Status
- Completed
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Congenital Heart Disease
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Theophylline Tablets
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult
- Enrollment
- 10
- Outcome Measure
- Feasibility and safety - adverse events, Frequency of treatment emerged AE/SAE, 12 weeks|Feasibility and safety - tolerability, Freedom from participant dropout based on tolerability of the study intervention, 12 weeks|Feasibility and safety - drug dosing, Number of participants requiring dose reduction after first serum concentration, 12 weeks|Feasibility and safety - arrhythmia, Freedom of arrhythmogenic side effects of the study treatment leading to patient dropout, 12 weeks|Cardiorespiratory fitness, Difference in oxygen uptake at anaerobic/ventilatory threshold pre/post treatment, 12 weeks
- Sponsor Collaborator
- Oslo University Hospital|South-Eastern Norway Regional Health Authority|Norwegian Health Association|Norwegian Association for Children with Congenital Heart Disease
- Funded By
- OTHER
- Location
- Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology, Oslo, 0424, Norway
- Other Id
- EU CT 2022-500301-41-00
- Start Date
- 2023-02-09
- Primary Completion Date
- 2023-09-15
- Completion Date
- 2023-09-15
- First Posted
- 2023-02-08
- Results First Posted
- Last Update Posted
- 2023-09-21
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/49/NCT05717049/Prot_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT05717049
- Title Cn
- Title En
- Theophylline Effects in the Fontan Circulation
- Bilingual Status
- semi_complete