Clinical trials: Pediatric Cardiology
Congenital Heart Disease
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery
The investigators hypothesize that intermittent bolus doses of morphine and midazolam can provide the same pain control after pediatric cardiothoracic surgery as bolus doses plus infusions while using smaller total doses of both…
- Trial name
- NCT02112448
- Testing
- continuous infusion, as needed dosing, Acetaminophen
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Wake Forest University Health Sciences
Childhood Stroke
TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors
The purpose of this study is to evaluate the tolerability of tDCS in childhood stroke survivors and to assess for improvement in arm function in patients receiving tDCS and occupational therapy
- Trial name
- TOPSS (NCT05812794)
- Testing
- Transcranial Direct Current Stimulation (tDCS)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- The University of Texas Health Science Center, Houston
Hypertension
An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension
The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which is in the same class of drug and is approved for use in the pediatric population aged 6 years and…
- Trial name
- NCT02235909
- Testing
- Azilsartan Medoxomil Low-dose, Losartan, Azilsartan Medoxomil Medium-dose (20 mg)
- Where
- 69 sites in United States, Argentina and 10 more
- Volunteers
- 377 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Hereditary Angioedema (HAE)
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in…
- Trial name
- NCT01386658
- Testing
- icatibant
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 32 people
- Sponsor
- Shire
Cardiovascular Disease, Childhood Obesity
PREVENT Tool Study: Late Effects Clinic
The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting.
- Trial name
- NCT04530825
- Testing
- Wait-List Control, PREVENT Tool
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Washington University School of Medicine
Fabry Disease
Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease
This is a long-term, Open-label Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Migalastat in Subjects > 12 Years of Age With Fabry Disease and Amenable GLA Variants
- Trial name
- NCT04049760
- Testing
- migalastat HCl 150 mg
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Amicus Therapeutics
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
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
Hypertension
A Study of Azilsartan in Children From 6 to Less Than 16 Years Old With High Blood Pressure
The main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure.
- Trial name
- NCT05107960
- Testing
- Azilsartan (TAK-536)
- Where
- Japan
- Volunteers
- 5 people
- Sponsor
- Takeda
Hypertension
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
- Trial name
- NCT00834041
- Testing
- Aliskiren 3.125 mini-tablets
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Novartis
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
Marfan Syndrome
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome
Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this condition die because of the associated heart and blood vessel abnormalities.
- Trial name
- NCT00429364
- Testing
- Losartan Potassium, Atenolol
- Where
- 26 sites in United States, Belgium and 1 more
- Volunteers
- 608 people
- Sponsor
- Carelon Research
Hypertension, Pulmonary
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months.
- Trial name
- NCT01342952
- Testing
- Ambrisentan
- Where
- 22 sites in United States, Argentina and 7 more
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Vitreoretinopathy, Coats' Disease
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery…
- Conditions
- Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration
- Trial name
- NCT05620901
- Testing
- Dextenza 0.4Mg Ophthalmic Insert, Pred Forte
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Lejla Vajzovic, MD, FASRS
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
Hypertension
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with…
- Trial name
- NCT01151410
- Testing
- Aliskiren, Enalapril
- Where
- 36 sites in United States, Guatemala and 5 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Cardiopulmonary Arrest, Resuscitation
Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR
The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac…
- Conditions
- Cardiopulmonary Arrest, Resuscitation, Pediatrics, Medication Errors
- Trial name
- NCT03921346
- Testing
- Mobile device app (PedAMINES™) 1st drug, Mobile device app (PedAMINES™) 2nd drug, Mobile device app (PedAMINES™) 3rd drug
- Where
- Switzerland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Pediatric Clinical Research Platform
Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD)
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively.
- Conditions
- Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD), Atrioventricular Septal Defects (AVSD)
- Trial name
- NCT00848393
- Testing
- Fentanyl (High Dose), Fentanyl (Low Dose), Fentanyl (Low Dose) + Dexmedetomidine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Nationwide Children's Hospital
Pulmonary Arterial Hypertension, Hypertension, Pulmonary
Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease. In many patients, the course of PAH is a steady deterioration and reduced life expectancy.
- Trial name
- NCT01642407
- Testing
- Sildenafil
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.