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Pharmacokinetics and pharmacodynamics of drugs in neonates and children during Cardiopulmonary Bypass.

This study is aimed at determining pharmacokinetics and pharmacodynamics of medications routinely used at the Erasmus Medical Centre in pediatric cardiac surgery during and after cardiopulmonary bypass. The goal is to be able to formulate evidence…

Bosentan in Exercise Induced Pulmonary Arterial Hypertension in Congenital Heart Disease

Identify congenital heart disease patients with exercise-induced pulmonary arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in patients with exercise induced pulmonary arterial hypertension before and after…

Evaluation of the VU-AMS device in pediatric cardiology

To evaluate the clinical usefulness of the VU-AMS in pediatric cardiology.To validate and improve the measures of stroke volume from the VU-AMS device. VU-AMS stroke volume measures will be compared with stroke volume measured by echocardiography.To…

Long term effects of congenital heart surgery. Cardiologic and Psychologic results. (LUCCA)

To get insight in the long term results (mortality, morbidity and cardiologic function) of patients with congenital heart disease operated at young age. To compare whether the changes in surgical techniques have resulted in an increase of (…

Comparison of wound closure in sternotomy scars: intracutaneous closure versus Steristrip-S

The aim of this study is 1. to compare scarformation in two different operative protocols in a prospective manner of children who undergo sternotomy because of cardiologic disease. 2. to differentioate scar pain from sternotomy pain. 3. to estimate…

Clinical study of the effect of PEEP ventilation on right ventricular afterload in pediatric patients after cardiac surgery.

The objective of the study is to investigate the effect of PEEP ventilation with or without a recruitment maneuver on right ventricular afterload in infants undergoing cardiac surgery.

Comparison between beta-adrenergic blockers and angiotensin II receptor antagonists for the treatment of late hypertension in patients with repaired aortic coarctation

To investigate whether treatment with candesartan (ARB) reduce 24-hours systolic BP and aortic stiffness more effectively than treatment with metoprolol (beta-blocker) in patients with repaired CoA and late hypertension.

Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

Establish the technical feasibility and safety of implantation of the investigational device, adjustment of the investigational device post-implantation and the ability of the investigational device to reduce mitral valve regurgitation.

The Effect of Exercise Training in Adult Patients with a Systemic Right Ventricle

The aim of the present study is to evaluate the effect of exercise training on exercise capacity, serum NT-proBNP levels and quality of life in adult patients with a systemic right ventricle.

A Phase III Open-Label, Single-Group, Extension Study to
Obtain Long-Term Safety and Tolerability Data of
Idebenone in the Treatment of Friedreich*s Ataxia Patients

- To gather long-term data on the safety and tolerability of idebenone inFriedreich*s Ataxia- To explore the effect of idebenone after longer term administration onneurological symptoms and signs as assessed by the InternationalCooperative Ataxia…

High dose statins in post-coarctectomy patients.

To reduce atherosclerotic progression in post-coarctectomy patients.

Regulation of colloid osmotic pressure during cardiopulmonary bypass in infants: prospective randomised trial.

The primary goal of this study is to compare the routinely use infant COP protocol (old protocol) with new approach to the COP regulation (new protocol) with regard to perioperative fluid shift, lung function and allogeneic transfusion requirements.…

European registry for ICD and CRT devices in pediatrics and adults with congenital heart disease (Euripides registry)

European registry of children and patients with congenital heart disease that undergo ICD or CRT implantation. This will lead to a larger amount of data leading to increased knowledge about long-term consequences and potential complications.

International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig shunt)

Primary:To evaluate the efficacy of 0.2 mg/kg/day of clopidogrel versus placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary…

Angiotensin II receptor blockers in patients with systemic right ventricles.

To study whether ARB's (valsartan) improves functional (contractile, electrophysiologic) performance of the right ventricle in adult patients with a systemic right ventricle.

Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system*

to improve RV function adult patients with RV dysfunction due to tetralogy of Fallot

A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome.

To demonstrate that macitentan improves exercise capacity in comparison with placebo in subjects with Eisenmenger Syndrome (ES).

Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease

To determine whether addition of selexipag to current PAH therapy improves exercise capacity, imaging parameters and quality of life, delays time-to-first-PAH-related morbidity and mortality, prevents worsening of World Health Organization…

CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass

This study has been transitioned to CTIS with ID 2024-513041-37-00 check the CTIS register for the current data. Primary objective of this study is to significantly reduce relevant (moderate/severe) parenchymatous brain injury on postoperative MRI…

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Primary• To evaluate the effect of CK-3773274 on exercise capacity (VO2) in patients with symptomatic oHCMSecondary• To evaluate the effect of CK-3773274 on patient health status• To evaluate the effect of CK-3773274 on New York Heart Association (…