Clinical trials: Heart Defects
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
Patent Ductus Arteriosus
Addition of Acetaminophen in Standard PDA Management
Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus…
- Trial name
- NCT04026464
- Testing
- Intravenous Ibuprofen, Intravenous Ibuprofen + Oral Acetaminophen
- Sponsor
- University of Florida
Patent Ductus Arteriosus, Patent Ductus Arteriosus - Delayed Closure
Timing of Surgical PDA Ligation and Neonatal Outcomes
Patent ductus arteriosus (PDA) is common among very preterm infants. If pharmacological closure is ineffective or contraindicated, surgical ligation may be required.
- Conditions
- Patent Ductus Arteriosus, Patent Ductus Arteriosus - Delayed Closure, Patent Ductus Arteriosus After Premature Birth
- Trial name
- NCT04126512
- Testing
- PDA ligation
- Where
- 2 sites in Italy, United Kingdom
- Volunteers
- 78 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Single-ventricle
Fibrosis and the Fontan
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics.
- Trial name
- NCT04901975
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Heart Disease
Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children
The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease.
- Trial name
- NCT03248830
- Testing
- radical-7 pulse co-oximeter
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Cairo University
Patent Ductus Arteriosus
An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants
A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular bleeding.
- Trial name
- NCT00750581
- Testing
- Indomethacin
- Where
- Canada
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Congenital Heart Disease, Cardiopulmonary Bypass
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1.
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation
- Trial name
- ILOCO (NCT07193719)
- Testing
- End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Charite University, Berlin, Germany
Fontan Procedure
Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles
Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study
- Trial name
- NCT03503032
- Testing
- Extracardiac Fontan, Fontan fenestration
- Where
- Saudi Arabia
- Volunteers
- 62 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome: Subendocardial Viability After Norwood Palliation
This project has several objectives ranging from clinical data analysis to computational simulations as listed below: 1. Retrospective review of all patients with HLHS treated surgically and followed medically at the IRCCS…
- Trial name
- HLHS (NCT05709275)
- Where
- Italy
- Volunteers
- 6 people
- Sponsor
- IRCCS Policlinico S. Donato
Patent Ductus Arteriosus, Preterm
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even…
- Trial name
- MIPD-PDA (NCT07143201)
- Testing
- Standard Dose - Ibuprofen oral suspension, Precision Dose - Ibuprofen oral suspension
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Hamilton Health Sciences Corporation
Congenital Heart Disease, Single-ventricle
Clinical Characteristics and Associations of the "Good Fontan" Patient
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse…
- Trial name
- NCT03470428
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Boston Children's Hospital
Heart Defects, Congenital
The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study
The purpose of the study is to determine whether it is possible to manage the flow of blood through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what effect this has on how well the major…
- Trial name
- NCT02358382
- Testing
- pH Stat
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Congenital Heart Disease
Precision Medicine in the CICU: Identifying Proteomic Biomarkers
Congenital Heart disease (CHD) is a leading cause of childhood death. Substantial morbidity and mortality relates to the postoperative course.
- Trial name
- NCT06642662
- Testing
- Somascan 5.0
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Children's Hospital
Mother-Infant Interaction
Bonding, Self-effıcacy and Vital Signs in Infants Undergoing Cardiovascular Surgery
Congenital heart diseases, the most common type of congenital anomalies, which affect approximately 3% of all live births and are the second most common cause of death in infants, are associated with 7% of all neonatal deaths.
- Trial name
- NCT06158373
- Testing
- infant massage practice, Safe Swaddling, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people
- Sponsor
- Istanbul University - Cerrahpasa
Congenital Heart Disease, Pulmonary Arterial Hypertension
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
The purpose of this study is to test the hypothesis that treating PAH-CHD patients preoperatively with PAH drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the…
- Trial name
- NCT01548950
- Testing
- Sildenafil singly or in association with Bosentan
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- University of Sao Paulo General Hospital
Turner Syndrome
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
The purposes of this study are to learn whether treatment with an androgen type hormone will improve the visual-spatial problems associated with Turner syndrome, and to evaluate the effect growth hormone, with and without…
- Trial name
- NCT00029159
- Testing
- estrogen, androgen
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Thomas Jefferson University
Patent Ductus Arteriosus
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA).
- Trial name
- PIVOTAL (NCT03982342)
- Testing
- Cather closure of patent ductus arteriosus (PDA), Conservative management of patent ductus arteriosus (PDA)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Nationwide Children's Hospital
Congenital Heart Defects
Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester
To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at a routine fetal scan in the second trimester of pregnancy
- Trial name
- NCT01201486
- Where
- Norway
- Volunteers
- 6,781 people
- Sponsor
- Helse Stavanger HF
Congenital Heart Defects
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
The purpose of this study is to understand how having a heart problem affects development,quality of life, and family life in young children and their families.
- Trial name
- NCT01567579
- Where
- United States
- Volunteers
- 928 people
- Sponsor
- Medical College of Wisconsin
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
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