Clinical trials: Cardiac Defects
Alagille Syndrome
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS).
- Trial name
- ASSERT-EXT (NCT05035030)
- Testing
- Odevixibat
- Where
- 35 sites in United States, Belgium and 8 more
- Volunteers
- 62 people
- Sponsor
- Albireo, an Ipsen Company
Patent Ductus Arteriosus
Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure
Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.
- Trial name
- NCT03026192
- Testing
- near infrared spectroscopy
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Albany Medical College
Congenital Heart Disease, Cardiovascular Disease
Technical Development for Pediatric Cardiovascular MRI
This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate pediatric patients with cardiovascular disease,congenital heart disease in patients of all ages, fetuses undergoing clinically indicated MR…
- Trial name
- NCT02892136
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Noonan Syndrome
Neuroradiological Features of Noonan Syndrome and Genotype-Phenotype Correlations
Retrospective and prospective collection of brain and spinal MRI and MR angiography images from patients of all ages with a genetically confirmed diagnosis of Noonan syndrome.
- Trial name
- NCT07881081
- Testing
- Brain MRI and MR angiography (MRA)
- Where
- 10 sites in Italy
- Volunteers
- 60 people
- Sponsor
- Istituto Giannina Gaslini
Tetralogy of Fallot (TOF), Pulmonary Stenosis
Investigation of Tetralogy of Fallot in Neonates
Child health serves as the foundation for overall public health, with neonatal mortality recognized globally as a comprehensive indicator of national health standards and societal advancement.
- Conditions
- Tetralogy of Fallot (TOF), Pulmonary Stenosis, Ventricular Septal Defects (VSD), Double Outlet Right Ventricle
- Trial name
- RIFAN (NCT06822400)
- Testing
- corrective surgery within 28 days of birth, corrective surgery between 3-6 months of age
- Where
- 5 sites in China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
Delirium - Postoperative, Sleep Problems
Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered…
- Conditions
- Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
- Trial name
- NCT06879431
- Testing
- cognitive-behavioral intervention
- Where
- China
- Volunteers
- 544 people
- Sponsor
- Yan Fuxia
Congenital Heart Disease
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
- Trial name
- DGX01 (NCT03877965)
- Testing
- Digoxin
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Christoph P Hornik, MD MPH
Congenital Heart Defects, Dysmorphic Facial Features and Intellectual Developmental Disorder
Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.
CDK13 related disorder is mainly characterised by developmental delay (DD) and intellectual disability (ID), ranging from mild to severe, and malformation syndrome.
- Trial name
- CDK13 (NCT04382573)
- Testing
- Epigenetic signatures
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Montpellier
Marfan Syndrome, Ehlers-Danlos Syndrome (EDS)
Multicentre Longitudinal Study of Bone Mineralisation Characteristics in Marfan Syndrome and Ehlers-Danlos Syndrome
The general objective of this research is to evaluate the characteristics of bone mineralisation in patients with Marfan syndrome or Ehlers-Danlos syndrome on a large case series.
- Conditions
- Marfan Syndrome, Ehlers-Danlos Syndrome (EDS), Mineral Density
- Trial name
- BONE (NCT07169669)
- Volunteers
- 150 people
- Sponsor
- IRCCS Policlinico S. Donato
Congenital Heart Disease, Acute Kidney Injury
Milrinone Pharmacokinetics and Acute Kidney Injury
Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery.
- Trial name
- MIL-PK (NCT01966237)
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Heart Disease
The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult…
- Trial name
- NCT01723332
- Testing
- Educational, Self management
- Where
- 2 sites in Canada
- Volunteers
- 120 people
- Sponsor
- University of Alberta
Ventricular Septal Defect, Pulmonary Hypertension
The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief…
- Trial name
- NCT01313832
- Testing
- remote ischemic preconditioning (RIPC)
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Seoul National University Hospital
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Tetralogy of Fallot
Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary…
- Trial name
- TOFandPVR (NCT03634072)
- Testing
- PVR
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
Alagille Syndrome
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.
- Trial name
- NCT07585097
- Where
- 14 sites in France, Italy
- Volunteers
- 30 people
- Sponsor
- Ipsen
Pain
Methadone Pharmacokinetics and Cardiac Effects in Newborns
The Primary objectives of this proposal are to determine the population kinetics for methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post menstrual age (PMA) who are 1 week old and older and…
- Trial name
- NCT00715988
- Testing
- Methadone HCl Inject 10 mg/ml (will require dilution), Methadone
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- University of Utah
Bronchopulmonary Dysplasia
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
- Trial name
- NCT01439295
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- St. Justine's Hospital
Congenital Heart Disease
Brain Function in Children With Congenital Heart Disease (CHD)
The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery…
- Trial name
- NCT02814539
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Bea Latal
Univentricular Heart, Lymphatic Abnormalities
Lymphatic Function in Patients With a Fontan Circulation From Brazil
It is suggested that the elevated central venous pressure in patients with a Fontan circulation can provoke manifestation of lymphatic dysfunction, met as plastic bronchitis, peripheral oedema and most feared protein-losing…
- Conditions
- Univentricular Heart, Lymphatic Abnormalities, Lymphatic Edema
- Trial name
- NCT04394507
- Testing
- Near-Infrared Fluorescence imaging, Strain Gauge Plethysmography
- Where
- 2 sites in Denmark
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Cardiac Diseases, Sickle Cell Disease
Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System
Cognizant of the prevalence of complicated non communicable diseases (NCD) and the attendant capacity problems faced by the health workers in primary care settings, we propose to adapt and pilot the Package of Essential…
- Conditions
- Cardiac Diseases, Sickle Cell Disease, Hypertension, Diabetes Mellitus
- Trial name
- PEN Plus (NCT07753681)
- Testing
- Supportive treatment
- Where
- Zambia
- Volunteers
- 2,084 people
- Sponsor
- Centre for Infectious Disease Research in Zambia