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Theophylline Effects in the Fontan Circulation
EU CTIS ID: 2022-500301-41-00
What this study is testing
1. To investigate feasibility and safety of a 12 weeks treatment study design with remote dosage titration and ambulatory heart rhythm monitoring during treatment phase 2. To provide an estimate of the effect size of 12 weeks of oral treatment with theophylline on exercise capacity in adolescents aged 16-25 years with univentricular congenital heart disease and Fontan circulation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.