Clinical trials: Pediatric Congenital Heart Disease
Congenital Heart Disease
dbGaP Protocol: The Pediatric Cardiac Genetics Consortium (PCGC)
Background: Researchers do not know much about the causes of congenital heart disease (CHD). They do know that many factors play a role. Some factors are environmental. Some are genetic.
- Trial name
- NCT03347214
- Where
- United States
- Volunteers
- 6,260 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
CHD - Congenital Heart Disease
Brain Ultrafast Ultrasound Imaging
Congenital heart defects affect 1 in 100 births in France, with rising prevalence due to better care. Despite improved survival, 40% of children post-surgery face neurological impairments, and some of them show brain lesions.
- Trial name
- Brain Ultrafas (NCT07299721)
- Testing
- Ultrafast ultrasound (UFUS)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Bordeaux
Congenital Heart Defect, Surgery-Induced Tissue Adhesions
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and…
- Conditions
- Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
- Trial name
- NCT01330433
- Testing
- CoSeal Surgical Spray Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Loma Linda University
Acute Heart Failure, Dilated Cardiomyopathy
Early Administration of Ivabradine in Children With Heart Failure
This is a monocentric, prospective, single arm, not for profit study. It is designed to study the early use of ivabradine in patients with dilated cardiomyopathy and Ejection Fraction (EF) < 45%.
- Trial name
- EASI-Child (NCT04405804)
- Testing
- Ivabradine 5Mg Tab
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- Bambino Gesù Hospital and Research Institute
Weight Gain, Body Mass Index
"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "
This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with…
- Conditions
- Weight Gain, Body Mass Index, Pediatric Nutrition, Congenital Heart Disease
- Trial name
- NCT07552688
- Testing
- High-Calorie Specialized Nutritional Formula, education program, High-Calorie Diet
- Where
- 2 sites in Iraq
- Volunteers
- 75 people
- Sponsor
- Aryan Najmadin Nasradin
Congenital Heart Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
Congenital Heart Disease
Partial Heart Transplantation
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible.
- Trial name
- NCT06055556
- Testing
- Partial Heart Transplantation, Freshly procured valve
- Where
- United States
- Sponsor
- Duke University
Lung Injury, Postoperative Complications
Ventilation During Cardiopulmonary Bypass
Postoperative pulmonary dysfunction (PPD) is a widely reported complication of cardiopulmonary bypass (CPB) although there is improvement in perioperative management, that leads to increased morbidity and mortality in cardiac…
- Conditions
- Lung Injury, Postoperative Complications, Pulmonary Collapse
- Trial name
- NCT04962542
- Testing
- ventilation
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Cairo University
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Congenital Heart Disease, Bicuspid Aortic Valve
Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve
Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the heart to the body) are not formed right.
- Trial name
- NCT00412386
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Emory University
Pediatric Heart Failure
Pumps for Kids, Infants, and Neonates
PumpKIN is a multicenter, prospective, single-arm feasibility study; Evaluating the investigational Jarvik 2015 VAD in pediatric patients with heart failure.
- Trial name
- PumpKIN (NCT02954497)
- Testing
- Surgical placement of the Jarvik 2015 VAD, Surgical Placement of Jarvik 2015 VAD
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Carelon Research
Shock, Sepsis
Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO
The purpose of this study is To assess the value of dynamics (SVV, PPV) and static indices (GEDVI, ITBVI, CVP) of preload and its combination with contractility (CI,SV, ventricular power, dP/dtmax, CFI, GEF) and lung water…
- Conditions
- Shock, Sepsis, Systemic Inflammatory Response Syndrome, Low Cardiac Output
- Trial name
- PreloaDren (NCT01157299)
- Where
- 7 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitario La Paz
Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers)
Cardiomyopathy is a disease of the heart muscle. It is rare, but it can be serious. Cardiomyopathy in children can result in death, disability, heart transplantation or serious heart rhythm disorders.
- Trial name
- NCT01873976
- Where
- 13 sites in United States, Canada
- Volunteers
- 288 people
- Sponsor
- Wayne State University
C.Surgical Procedure; Cardiac, Blood Coagulation Disorders
Fibrinogen Concentrate In Children Cardiac Surgery 2
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
- Conditions
- C.Surgical Procedure; Cardiac, Blood Coagulation Disorders, Hypofibrinogenemia
- Trial name
- FiCCS2 (NCT03884725)
- Testing
- Fibrinogen Concentrate, control
- Where
- Brazil
- Volunteers
- 42 people
- Sponsor
- Filomena R B G Galas
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD)…
- Conditions
- Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications
- Trial name
- NCT07375602
- Where
- China
- Volunteers
- 5,249 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy
Comparison of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block for Postoperative Analgesia in Pediatric Cardiac Surgery
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial…
- Conditions
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- Trial name
- NCT07740915
- Testing
- Ultrasound-Guided Erector Spinae Plane Block, Ultrasound-Guided Modified Pectoral Fascial Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Heart Defects, Congenital
Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery
Directly following cardiac surgery for congenital heart disease; patients are not receiving routine turning every two hours to prevent pressure ulcers, because a negative influence on hemodynamic parameters is assumed.
- Trial name
- NCT02622152
- Testing
- Right lateral position (2 hours), Left lateral position (30 minutes), Supine position (30 minutes)
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Congenital Heart Disease
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
Malformations of the heart are common; 1.35 million infants are born each year with congenital heart disease. Many of these defects carry a considerable threat to the individual's quality of life as well as survival.
- Trial name
- ULTRA (NCT04920643)
- Testing
- Ultrafiltration
- Where
- Canada
- Volunteers
- 104 people
- Sponsor
- IWK Health Centre
Adult Congenital Heart Disease, Congenital Heart Disease
Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease
The purpose of this study, entitled "Psychological trauma, post-traumatic stress disorder, and resilience in adults with congenital heart disease in a large population sample", is to evaluate for exposures during a lifetime with…
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, PTSD
- Trial name
- PTSD in ACHD (NCT06952933)
- Testing
- Other
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Congenital Heart Disease in Children
Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
Children undergoing cardiac surgery or cardiac catheterization often experience significant stress and anxiety during the preoperative period.
- Trial name
- GETREADY (NCT07414251)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Charite University, Berlin, Germany