Heart disease congenital – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Mon, 22 Jun 2026 04:02:05 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Heart disease congenital – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Safety and pharmacodynamics of cangrelor tetrasodium in paediatric patients with congenital heart disease undergoing percutaneous vascular procedures https://clinicaltrials.eu/trial/safety-and-pharmacodynamics-of-cangrelor-in-children-birth-to-17-years-with-congenital-heart-disease-undergoing-vascular-procedures/ Wed, 17 Jun 2026 04:03:06 +0000 https://clinicaltrials.eu/trial/safety-and-pharmacodynamics-of-cangrelor-in-children-birth-to-17-years-with-congenital-heart-disease-undergoing-vascular-procedures/ The study focuses on children from birth to under 18 years who have Congenital Heart Disease, a condition where the heart’s structure is different from normal at birth. During heart‑related procedures that involve inserting a thin tube through a blood vessel, participants will receive an intravenous medication called Cangrelor that works to keep platelets from forming clots while the procedure is performed.

The purpose of the study is to evaluate the safety of the recommended dose of this medication in the pediatric population. Children who need diagnostic or therapeutic percutaneous vascular procedures will be given the drug during the procedure and then observed for several days. Researchers will watch for any bleeding, breathing problems such as wheezing or shortness of breath, changes in kidney function, vital signs like heart rate and blood pressure, and any other side effects that may occur.

After the infusion, participants remain in the hospital for monitoring, and follow‑up checks may be scheduled to ensure recovery and to record any adverse events. The study collects information on how well the medication is tolerated, without using any comparison or placebo, and aims to provide data that could help improve care for children with this heart condition.

]]> Study on Allopurinol Sodium for Brain Injury Prevention in Newborns with Critical Congenital Heart Disease Undergoing Heart Surgery https://clinicaltrials.eu/trial/study-on-allopurinol-sodium-for-brain-injury-prevention-in-newborns-with-critical-congenital-heart-disease-undergoing-heart-surgery/ Wed, 29 Apr 2026 15:01:09 +0000 https://clinicaltrials.eu/trial/study-on-allopurinol-sodium-for-brain-injury-prevention-in-newborns-with-critical-congenital-heart-disease-undergoing-heart-surgery/ This clinical trial is focused on studying brain injury in newborns with critical congenital heart disease who need heart surgery using a method called cardiopulmonary bypass. The treatment being tested is a medication called allopurinol sodium, which is given as a solution through a vein. The study will compare the effects of allopurinol sodium to a placebo to see if it can reduce brain injury in these newborns.

The purpose of the study is to find out if giving allopurinol sodium shortly after birth and around the time of heart surgery can help protect the brain from injury. The study will involve monitoring the newborns before and after surgery using various methods, including MRI scans to check for brain injury, and other tests to assess brain and heart function. The study will also look at the overall development of the children as they grow, including their movement and cognitive skills at different ages.

Throughout the study, researchers will gather information on how well allopurinol sodium works and its cost-effectiveness. The study aims to provide valuable insights into whether this treatment can improve outcomes for newborns with critical congenital heart disease undergoing surgery.

]]> Study Comparing Custodiol-N and Custodiol for Heart Surgery in Children with Congenital Heart Defects https://clinicaltrials.eu/trial/study-comparing-custodiol-n-and-custodiol-for-heart-surgery-in-children-with-congenital-heart-defects/ Wed, 29 Apr 2026 15:00:35 +0000 https://clinicaltrials.eu/trial/study-comparing-custodiol-n-and-custodiol-for-heart-surgery-in-children-with-congenital-heart-defects/ This clinical trial is focused on studying a condition known as in children. This condition involves structural problems with the heart that are present from birth. The study will compare two different solutions used during heart surgery to protect the heart. These solutions are called and . Custodiol-N is a solution for organ preservation, containing substances like , , and , while Custodiol is a solution for cardioplegia, which includes substances such as , , and . The purpose of the study is to assess the safety of these solutions during surgery.

Participants in the study will undergo heart surgery due to congenital heart malformation. During the surgery, one of the two solutions will be used to protect the heart. The study will monitor the safety of these solutions by observing any adverse events, which are unexpected medical problems, for up to 30 days after the surgery. Additionally, the study will evaluate how well the heart is protected by measuring certain enzymes in the blood, like CK-MB, which can indicate heart muscle damage, until seven days after the surgery.

The study will also gather information on various aspects of the participants’ recovery, such as heart function, hospital stay duration, and any need for additional heart support. This includes monitoring vital signs, blood parameters, and the use of medications like catecholamines and milrinone, which help support heart function. The study aims to provide valuable insights into the effectiveness and safety of these solutions in protecting the heart during surgery for congenital heart malformation in children.

]]> Study on Theophylline for Improving Exercise Capacity in Adolescents with Univentricular Heart Disease and Fontan Circulation https://clinicaltrials.eu/trial/study-on-theophylline-for-improving-exercise-capacity-in-adolescents-with-univentricular-heart-disease-and-fontan-circulation/ Wed, 29 Apr 2026 14:25:12 +0000 https://clinicaltrials.eu/trial/study-on-theophylline-for-improving-exercise-capacity-in-adolescents-with-univentricular-heart-disease-and-fontan-circulation/ This clinical trial is focused on studying the effects of the medication Theophylline in individuals with a specific type of heart condition known as univentricular congenital heart disease that has been treated with a Fontan-type surgical palliation. The medication being tested is called Theo-Dur 200mg depottablett, which is a prolonged-release tablet taken orally. The purpose of the study is to explore the feasibility and safety of a 12-week treatment plan, which includes adjusting the dosage remotely and monitoring heart rhythm during the treatment phase.

Participants in the study will be adolescents aged 16 to 25 years who have undergone the Fontan procedure. The study will estimate the effect of 12 weeks of oral treatment with Theophylline on exercise capacity. Throughout the study, participants will be monitored for any side effects and changes in their ability to exercise. The study will also assess differences in oxygen uptake, which is a measure of how well the body uses oxygen during physical activity, before and after the treatment.

In addition to exercise capacity, the study will evaluate other health aspects such as quality of life through questionnaires, heart function using echocardiography (a type of ultrasound for the heart), and breathing capacity. Participants will also undergo a home-based sleep study to check for changes in sleep patterns. The study aims to provide valuable insights into the potential benefits and safety of Theophylline for young people with this heart condition.

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