Clinical trials: Pediatric Cardiology
Heart Disease
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography.
- Trial name
- NCT02282163
- Testing
- sulphur hexafluoride lipid-type A microspheres
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bracco Diagnostics, Inc
Hypertension
Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)
The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old.
- Trial name
- HIP (NCT00690612)
- Testing
- candesartan cilexetil
- Where
- 13 sites in Belgium, France and 4 more
- Volunteers
- 35 people
- Sponsor
- AstraZeneca
Hereditary Angioedema
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including…
- Trial name
- NCT01359969
- Testing
- rhC1INH
- Where
- 16 sites in United States, Czechia and 8 more
- Volunteers
- 57 people
- Sponsor
- Pharming Technologies B.V.
Heart Failure
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2…
- Trial name
- NCT03785405
- Testing
- sacubitril/valsartan
- Where
- 79 sites in United States, Argentina and 25 more
- Volunteers
- 216 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
- Trial name
- NCT00756938
- Testing
- losartan potassium
- Volunteers
- 101 people
- Sponsor
- Organon and Co
Pediatric Obesity, Insulin Resistance
Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity
The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems…
- Conditions
- Pediatric Obesity, Insulin Resistance, Impaired Glucose Tolerance, Cardiovascular Disease
- Trial name
- NCT00846521
- Testing
- Acarbose
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Yale University
Hypofibrinogenemia, Afibrinogenemia
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
- Conditions
- Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
- Trial name
- RiaSTAP (NCT02822599)
- Testing
- RiaStAP, Saline
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Cardiopulmonary Arrest, Pediatric ALL
Impact of 2 Resuscitation Sequences on Management of Simulated Pediatric Cardiac Arrest
The International Liaison Committee on Resuscitation regularly publishes a Consensus on Science with Treatment Recommendations but guidelines can nevertheless differ when knowledge gaps persist.
- Conditions
- Cardiopulmonary Arrest, Pediatric ALL, Resuscitation
- Trial name
- NCT05474170
- Testing
- AHA resuscitation sequence, ERC resuscitation sequence
- Where
- Switzerland
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Geneve TEAM Ambulances
Congenital Disorders
Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients
Long QT syndrome (LQTS)is a cardiac disorder that may lead to ventricular arrythmias and culminate in syncope and/or possible death.
- Trial name
- LEAP (NCT00548886)
- Testing
- Epinephrine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Emory University
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Vitamin D Deficiency, Thoracic Surgery
Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery.
- Conditions
- Vitamin D Deficiency, Thoracic Surgery, Pediatric Disorders, Heart Defects, Congenital
- Trial name
- HICCUPS 2 (NCT01838447)
- Testing
- Cholecalciferol
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- Children's Hospital of Eastern Ontario
Pulmonary Hypertension
Sedation With Dexmedetomidine During Cardiac Catheterization
Clinical dose escalation drug trial to evaluate the effect of 3 different doses of dexmedetomidine on the pulmonary vascular bed in pediatric subjects with elevated pulmonary vascular resistance (PVR).
- Trial name
- NCT01072643
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Aruna Nathan
Hypoxemia, Arrhythmias
Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning
Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.
- Conditions
- Hypoxemia, Arrhythmias, Cardiac Arrest, Ventilator Associated Pneumonia
- Trial name
- NCT01069185
- Testing
- Necessity endotracheal suctioning, Routine endotracheal suctioning
- Where
- Colombia
- Volunteers
- 92 people
- Sponsor
- Hospital Pablo Tobón Uribe
Congenital Heart Defect
Erythropoietin and Pediatric Cardiac Surgery
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may…
- Trial name
- EPO (NCT00451698)
- Testing
- acyanotic erythropoietin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical College of Wisconsin
Heart Defects, Congenital, Heart Failure, Congestive
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle.
- Trial name
- ISV (NCT00113087)
- Testing
- Enalapril
- Where
- 9 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Pediatric Cancer, Thrombocytopenia
A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia
This study evaluates the use of tranexamic acid (TXA) in addition to standard therapy in children receiving chemotherapy or blood and/or marrow transplantation to decrease the risk of bleeding.
- Conditions
- Pediatric Cancer, Thrombocytopenia, Hemostatic Disorder, Coagulation Defect; Acquired
- Trial name
- NCT03806556
- Testing
- Tranexamic Acid, Normal saline
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Meghan McCormick
Fabry Disease
Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)
This was an open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric participants 12 to <18 years of age with Fabry disease and amenable gene…
- Trial name
- NCT03500094
- Testing
- Migalastat HCl 150 mg
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 22 people
- Sponsor
- Amicus Therapeutics
Congenital Heart Disease
Influence of Genetic Polymorphisms on Ventricular Structure and Function in Patients With Single Ventricle Anatomy
There are many kids born with congenital heart disease. Some of these defects may lead to the formation of a single ventricle (the heart having only one pumping chamber).
- Trial name
- NCT00165984
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Emory University
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.