Theophylline Effects in the Fontan Circulatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Participant must be 16 to 25 years of age inclusive, at the time of signing the informed consent., Participants with univentricular congenital heart disease with a Fontan-type palliation a.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. b.With available hepatic imaging results (ultrasound or magnetic resonance imaging) from less than 12 months before inclusion c.Without biochemical indications of more than mild liver disease or liver failure (see exclusion criteria) of severe reduced kidney function. d.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 should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies., 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. Acceptable methods of contraception are defined in protocol section 10.4.1 and 10.4.2, 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. For participants < 18 years, all (both) parents or caregivers with parental responsibilities have to sign the consent form in addition to the participant.

Exclusion Criteria

Current or previous (last 12 months) tachyarrhythmia which has been cause of medical investigation or hospitalization., Current treatment with pulmonary vasodilator medication (sildenafil, tadalafil, udenafil, bosentan, ambrisentan, macicentan, or any prostacyclin derivate), Hypersensitivity to theophylline, Ongoing pharmacological treatment with the risk of drug-drug interactions. (Examples: cimetidine, chinoline derivates like enoxacin, ciprofloxacin, perfloxacin, viloxazin, makrolid antibiotics like erytromycin, troleandomycin, allopurinol, propranolol, disulfiram, isoniazid, oral contraconceptives, flu vaccine, mexiletine, nifedipine, norfloxacine, ranitidin, tiabendazol, verapamil, fluvoxamine, carbamazepine, felodipine, phenobarbital, phenytoin, rifampicine, lithium, ketamine, glucagon), Heart rhythm during inclusion visit other than: - sinus rhythm or regular supraventricular rhythm (visible P-waves) regardless P-wave angle - nodal rhythm, Systemic hypertension (systolic or diastolic blood pressure above 95 percentile), Biochemical signs of more than mild liver disease or liver failure indicated by one of the following: a.INR > 1.4 in the absence of warfarin treatment or treatment with direct oral anticoagulants, b.ALAT more than twice the upper normal limit c.Bilirubin more than twice the upper normal limit, Imaging signs from the recent 12 months indicating severe Fontan-associated liver disease, indicated by: a.Imaging findings that need further diagnostic work-up to rule out hepato-cellular carcinoma, Biochemical indication of more than mildly reduced kidney function indicated by: a.Creatinine > 150 µmol/L (male) or > 120 µmol/L (female), Pregnancy or breastfeeding, Inherited forms of galactose intolerance (Lapp lactase deficiency eller glucose-galactose malabsorption

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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