Clinical trials: Inherited Cardiac Conditions
Friedreich Ataxia, Cardiomyopathies
Phase IA and IB Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia
The purpose of this study is to test the safety and preliminary efficacy of AAVrh.10hFXN to treat the cardiomyopathy associated with Friedreich's ataxia (FA).
- Conditions
- Friedreich Ataxia, Cardiomyopathies, Cardiac Hypertrophy, Myocardial Fibrosis
- Trial name
- NCT05302271
- Testing
- AAVrh.10hFXN, serotype rh.10 adeno-associated virus (AAV) gene transfer vector expressing the cDNA coding for human FXN, Prednisone
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Weill Medical College of Cornell University
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
Congenital Heart Disease
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.
- Trial name
- NCT00868101
- Testing
- Remote ischemic preconditioning
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- University of Sao Paulo
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
Retinopathy of Prematurity, Pain
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination…
- Conditions
- Retinopathy of Prematurity, Pain, Premature Infant, Retinal Disease
- Trial name
- MASK-ROP (NCT03824782)
- Testing
- Phototherapy Mask
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- Sunnybrook Health Sciences Centre
CHD, Heart Defects, Congenital
The Effects of Different Prone Positioning Angles on Cardiopulmonary Function in Children After Congenital Heart Disease Surgery: A Randomized Controlled Trial
The goal of this randomized controlled trial is to learn if different head-elevated prone positioning angles can optimize cardiopulmonary function and enteral nutrition tolerance in infants and children after congenital heart…
- Conditions
- CHD, Heart Defects, Congenital, Hypoxia, Respiratory Insufficiency
- Trial name
- PACE-CHD (NCT07323979)
- Testing
- 10° Head-Elevated Prone Positioning, 30° Head-Elevated Prone Positioning, 45° Head-Elevated Prone Positioning
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Guangdong Provincial People's Hospital
Procedural Pain, Congenital Heart Disease
Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease
The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease.
- Conditions
- Procedural Pain, Congenital Heart Disease, Heart Surgery, Hypnosis
- Trial name
- PEACE-HYPNO (NCT06373627)
- Testing
- Hypnosis, Conventional medications used for sedation-analgesia, Medications used in addition to hypnosis
- Volunteers
- 104 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Velocardiofacial Syndrome
Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome
This study will test a computer-based treatment for youth with the genetic disorder velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and executive functioning.
- Trial name
- NCT00917189
- Testing
- Challenging Our Minds Program
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- State University of New York - Upstate Medical University
Congenital Heart Disease (CHD)
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. In preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe.
- Trial name
- BASICS-Kids (NCT06882772)
- Testing
- 2 mL SunButyrate-TG, 4 mL SunButyrate-TG
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of Nebraska
Growth Failure, Neurodevelopmental Disorder
High Energy Formula Feeding in Infants With Congenital Heart Disease
High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula
- Trial name
- NCT01850784
- Testing
- High energy formula, Standard formula
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Fetal Growth Retardation
Day to Day Variation in Fetal Heart Rate Variability
This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.
- Trial name
- (FHRV) (NCT04289350)
- Testing
- fetal heart rate variability
- Where
- Denmark
- Volunteers
- 44 people
- Sponsor
- University of Aarhus
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
Alagille Syndrome, Cholestasis
Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.
- Conditions
- Alagille Syndrome, Cholestasis, Biliary Atresia
- Trial name
- NCT00007033
- Testing
- magnesium gluconate, magnesium sulfate
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Center for Research Resources (NCRR)
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, Perioperative/Postoperative Complications
Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery
The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit.
- Conditions
- Congenital Heart Disease, Perioperative/Postoperative Complications, Lactate Blood Increase
- Trial name
- VACO2 (NCT06292910)
- Testing
- arterial and central venous blood gas analysis, lactate
- Where
- Thailand
- Volunteers
- 136 people
- Sponsor
- Prince of Songkla University
Sudden Cardiac Death, Sudden Cardiac Arrest
Low QRS Voltages in Young Healthy Individuals and Athletes
There is some limited evidence that reduced size of electrical complexes/traces of the heart on the electrocardiogram (ECG) may be associated with scarring in the heart muscle, which may predispose to serious life-threatening…
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest, Sudden Cardiac Death Due to Cardiac Arrhythmia, Arrhythmogenic Right Ventricular Cardiomyopathy
- Trial name
- NCT05799833
- Testing
- Cardiovascular magnetic resonance scan - 3T scanner (Siemens Vida)
- Where
- United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Williams Syndrome
Motor Deficits and Signal Conduction in Individuals With Williams Syndrome
The current study aims to validate basic research findings of abnormal conductivity and motor abilities from a mouse model in humans.
- Trial name
- NCT05430763
- Where
- Israel
- Sponsor
- Sheba Medical Center
Breath-holding Spell
Breath-holding Spells and Its Management Study
The goal of this prospective population-based study is to evaluate the new disease description and management guidelines for breath-holding spells in children (Hellström Schmidt et al, Acta Paediatrica 2024) below the age of 5…
- Trial name
- BAM (NCT06628271)
- Testing
- Guidelines
- Where
- 12 sites in Sweden
- Volunteers
- 120 people
- Sponsor
- Region Skane
Congenital Heart Disease (CHD)
Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds
This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone…
- Trial name
- AUSC-CHD (NCT07376785)
- Testing
- Computer algorithms
- Where
- 2 sites in Hong Kong
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong