Clinical trials: Defect, Congenital Heart
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
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Structural Heart Abnormality
The SALMANTICOR Study
The SALMANTICOR study will obtain data on the prevalence and incidence of structural heart disease in a population setting. A cross-section survey of randomly selected residents of Salamanca (Spain) will be performed.
- Trial name
- SALMANTICOR (NCT03429452)
- Where
- Spain
- Volunteers
- 2,057 people
- Sponsor
- AORTICA Group
Congenital Heart Disease
Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood
The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases.
- Trial name
- NCT03917706
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 118 people
- Sponsor
- Pierre Wauthy
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
Hypoplastic Left Heart Syndrome, Aortic Coarctation
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
- Conditions
- Hypoplastic Left Heart Syndrome, Aortic Coarctation, Atrial Septal Aneurysm
- Trial name
- NCT03147014
- Testing
- Maternal hyperoxygenation
- Where
- China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Beijing Anzhen Hospital
Heart Failure, Dilated Cardiomyopathy
Myocardial Telomere Recapping Study for Dilated Cardiomyopathy
The aim of this study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing a modified telomerase protein (TERT), driven by cardiac troponin T promoter (AAV9-cTnT-modTERT), to 12 dilated…
- Trial name
- MERCURY-DCM (NCT05837143)
- Testing
- JV001
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai East Hospital
Hypoplastic Left Heart Syndrome
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with…
- Trial name
- NCT03779711
- Testing
- Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
- Where
- 8 sites in United States
- Volunteers
- 95 people
- Sponsor
- Timothy J Nelson, MD, PhD
Magnetic Resonance Imaging, Tetralogy of Fallot
4D Velocity Mapping of the Heart in rTOF Patients
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.
- Trial name
- CARDIOFLUX (NCT02980614)
- Testing
- 4D flow imaging
- Where
- France
- Volunteers
- 21 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
DiGeorge Anomaly, DiGeorge Syndrome
Thymus Transplantation Dose in DiGeorge #932
One purpose of this study is to determine whether the amount of cultured thymus tissue implanted into DiGeorge anomaly infants has any effect on the immune outcome.
- Conditions
- DiGeorge Anomaly, DiGeorge Syndrome, Complete DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- NCT00576836
- Testing
- Cultured Thymus Tissue Implantation (CTTI), Cultured Thymus Tissue Implantation with Parathyroid Transplantation
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Labor, Epidural Analgesia
Pulse Pressure Variability With Position Before EPIdural Analgesia
Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than…
- Trial name
- PP-PERI (NCT03126136)
- Testing
- Nicom (TM)
- Where
- 4 sites in France
- Volunteers
- 1 people
- Sponsor
- Hopital Foch
Dilated Cardiomyopathy, Arrhythmogenic Cardiomyopathy
Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy
Risk stratification for sudden cardiac death (SCD) in patients with non-ischemic cardiomyopathy (NICM) remains suboptimal. Although current guidelines rely on severe left ventricular systolic dysfunction (left ventricular…
- Conditions
- Dilated Cardiomyopathy, Arrhythmogenic Cardiomyopathy, Ventricular Arrhythmia, Hypertrophic Cardiomyopathies
- Trial name
- IMPROVE-NICM (NCT06730464)
- Where
- 4 sites in Italy, Portugal and 1 more
- Volunteers
- 500 people
- Sponsor
- Centro Medico Teknon
Congenital Heart Disease, Fetal Heart Disorder
Perinatal Cardiology: Bridging Obstetric and Neonatal Care in CHD
This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on…
- Conditions
- Congenital Heart Disease, Fetal Heart Disorder, Neonatal Disease, Fetal Disease
- Trial name
- NCT07820163
- Volunteers
- 115 people
- Sponsor
- Assiut University
Congenital Heart Disease (CHD), Mentorship
Optimizing Care Transitions in CHD
Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses.
- Conditions
- Congenital Heart Disease (CHD), Mentorship, Transition of Care, Peer Support
- Trial name
- NCT07898384
- Testing
- Peer mentorship
- Where
- Canada
- Volunteers
- 110 people
- Sponsor
- The Hospital for Sick Children
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates…
- Conditions
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
- Trial name
- NCT02462434
- Testing
- Early palliative care team consultation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Congenital Heart Disease, Covid-19
Impact of Covid-19 in Congenital Heart Disease
The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70…
- Trial name
- COVID-CHD (NCT04336384)
- Where
- France
- Volunteers
- 5,000 people
- Sponsor
- University Hospital, Montpellier
Congenital Heart Disease (CHD), Postoperative Respiratory Dysfunction
Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery.
This study examines the effects of coughing exercises and incentive spirometry (IS) on lung function and recovery in children who undergo heart surgery.
- Conditions
- Congenital Heart Disease (CHD), Postoperative Respiratory Dysfunction, Postoperative Recovery After Cardiac Surgery
- Trial name
- CEXIS (NCT07405333)
- Testing
- Coughing Exercises, Incentive Spirometry, Standard Postoperative Care
- Where
- 4 sites in Iraq
- Volunteers
- 99 people
- Sponsor
- University of Baghdad
Congenital Heart Defect, Dental Caries in Children
Oral Health Intervention Program for Children With Congenital Heart Defects
Background: Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children.
- Conditions
- Congenital Heart Defect, Dental Caries in Children, Dental Erosion, Dental Plaque
- Trial name
- NCT03311438
- Testing
- Oral health intervention program
- Volunteers
- 75 people
- Sponsor
- University of Bergen
Long QT Syndrome, Brugada Syndrome
Healthy-related Quality of Life and Physical Activity of Children With Cardiac Malformations
The QUALIMYORYTHM trial is a multicentre controlled study, aiming to assess health-related quality of life (HRQoL) of 107 children aged 6 to 18 years old with inherited cardiac arrhythmia (long QT syndrome, Brugada syndrome…
- Conditions
- Long QT Syndrome, Brugada Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia, Arrhythmogenic Right Ventricular Dysplasia
- Trial name
- QUALIMYORYTHM (NCT04712136)
- Testing
- MRI
- Where
- France
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Nutrition Disorder, Child
Efficacy and Safety of the Algorithm for Enteral Nutrition Support
The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart…
- Trial name
- NCT04609358
- Testing
- intervention group
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
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