Clinical trials: Heart Defects
Down Syndrome, Congenital Heart Disease
Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD) repair and children from the same clinical sites…
- Trial name
- CHILD-DS (NCT05312177)
- Testing
- Stanford Binet Intelligence Scales, Fifth Edition, Vineland Adaptive Behavior Scales Third Edition, Peabody Picture Vocabulary Test, Fifth Edition
- Where
- 14 sites in United States, Canada
- Volunteers
- 273 people, healthy volunteers welcome
- Sponsor
- Carelon Research
Congenital Heart Disease
Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)
The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.
- Trial name
- NCT01698567
- Testing
- Antithrombin III
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Rochester
Congenital Heart Disease
Assessing Neurodevelopment in Congenital Heart Disease.
Congenital heart disease (CHD) is the most prevalent congenital malformation affecting 1 in 100 newborns per year. Children with CHD are a known risk population for brain injury, with neurodevelopmental alterations shown over…
- Trial name
- NEUROHEART (NCT02996630)
- Testing
- Sonography, Magnetic Resonance Imaging, Bailey Test
- Where
- Spain
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Single-ventricle
Re-Energize Fontan
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high.
- Trial name
- NCT04195451
- Testing
- Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stanford University
Heart Failure, Congenital Heart Disease
Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease
Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its…
- Trial name
- LENA-WP09 (NCT02652741)
- Testing
- Enalapril Orodispersible Minitablet
- Where
- 6 sites in Austria, Hungary and 3 more
- Volunteers
- 50 people
- Sponsor
- Ethicare GmbH
HCM, Noonan Syndrome and Other Rasopathy
Clinical Trial of a MEK Inhibitor for RASopathy-Associated Severe Infantile Hypertrophic Cardiomyopathy: Baby MERIT
This project seeks to perform a Phase 3 clinical trial to test whether an FDA-approved cancer drug called trametinib is effective in treating young infants with genetic conditions called RASopathies and a severe, life-threatening…
- Conditions
- HCM, Noonan Syndrome and Other Rasopathy, Heart Failure (Pediatric)
- Trial name
- Baby MERIT (NCT07817186)
- Testing
- Trametinib
- Volunteers
- 25 people
- Sponsor
- Carelon Research
Oral Health, Dental Caries
Improved Oral Health and Dental Care in Children with Congenital Heart Disease
Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in children. As the risk for endocarditis following bacteraemia is more common during daily oral hygiene routines, such as tooth brushing…
- Trial name
- ORALPEDHEART (NCT03329170)
- Testing
- educational intervention using motivational interviewing
- Where
- Finland
- Volunteers
- 150 people
- Sponsor
- My Blomqvist
Patent Ductus Arteriosus
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus
The purpose of this study is to examine if a higher dose of indomethacin will increase the rate of ductus arteriosus closure in extremely premature infants without increasing the side effects.
- Trial name
- NCT00187447
- Testing
- indomethacin (two different dosing regimens)
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of California, San Francisco
Congenital Heart Disease
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will…
- Trial name
- IMMPACT (NCT03891160)
- Testing
- 3D model of heart
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Columbia University
Congenital Heart Disease
Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
This study aims to examine performance on a neurological screening test, the Dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with congenital heart disease (CHD) as a way to…
- Trial name
- NCT01291797
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitochondrial Diseases, Barth Syndrome
An Intermediate Size Expanded Access Protocol of Elamipretide
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program.
- Trial name
- NCT04689360
- Testing
- elamipretide
- Sponsor
- Stealth BioTherapeutics Inc.
Congenital Heart Disease
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.
- Trial name
- NCT00848250
- Testing
- Angiotensin Converting Enzyme Inhibitor, No ACE Inhibitor
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Vanderbilt University Medical Center
Growth Hormone Deficiency, Idiopathic Short Stature
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Trial name
- NCT04798690
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Dong-A ST Co., Ltd.
Congenital Heart Disease
The Relationship Between Having a Positive Mindset and Exercise Capacity in Patients With Congenital Heart Disease
A cross sectional study utilizing congenital heart disease patients presenting for clinically indicated cardiopulmonary exercise test. Baseline questionnaires (see below) will be administered prior to the exercise test.
- Trial name
- NCT03912025
- Testing
- Relationship between positive mindset and exercise capacity
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Boston Children's Hospital
Heart Defects, Congenital
Long-term Survival After Single-ventricle Palliation
A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively.
- Trial name
- NCT03356574
- Testing
- Single-ventricle palliation surgery
- Where
- 2 sites in Sweden
- Volunteers
- 800 people
- Sponsor
- Karolinska University Hospital
Eye Diseases Hereditary, Retinal Disease
Inherited Retinal Degenerative Disease Registry
The My Retina Tracker® Registry is sponsored by the Foundation Fighting Blindness and is for people affected by one of the rare inherited retinal degenerative diseases studied by the Foundation.
- Conditions
- Eye Diseases Hereditary, Retinal Disease, Achromatopsia, Bardet-Biedl Syndrome
- Trial name
- MRTR (NCT02435940)
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Foundation Fighting Blindness
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Heart Defects, Congenital, Hypertension, Pulmonary
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Trial name
- NCT00335244
- Testing
- L-citrulline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Cardiac Arrest, Congenital Heart Disease
Resuscitation Registry in CHD
Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially…
- Trial name
- PRO-CHD (NCT05373498)
- Where
- 3 sites in Germany
- Volunteers
- 400 people
- Sponsor
- Leipzig Heart Science gGmbH
Right Ventricular Dysfunction
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction.
- Trial name
- TOF-Cond (NCT00557934)
- Testing
- dobutamine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital Tuebingen
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