Clinical trials: Pediatric Cardiac Transplantation
Heart Transplantation
Thymic Tolerance in Pediatric Heart Transplantation
The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe.
- Trial name
- NCT00151164
- Testing
- donor bone marrow cell injection into thymus gland
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
Cardiac Transplantation
Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients
This protocol is designed to obtain information on the drug levels, metabolism, and safety of daclizumab (Zenapax(R)) in children and adolescents undergoing cardiac transplantation.
- Trial name
- NCT00284531
- Testing
- Daclizumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baylor College of Medicine
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Congenital Disorders
Daclizumab Experience in Pediatric Heart Transplant
The purpose of this study is to examine the outcomes of those who have received Daclizumab as part of their immuno-suppression protocol following heart transplantation.
- Trial name
- NCT00486057
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Children's Healthcare of Atlanta
Cardiomyopathy
Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy
According to the high morbidity and mortality of idiopathic Dilated CardioMyopathy (IDCM) in pediatric, new modality of treatment is emerging. There are some case reports of administration of stem cell therapy.
- Trial name
- NCT02256501
- Testing
- Mono Nuclear Cell (MNC) transplantation
- Where
- Iran
- Volunteers
- 30 people
- Sponsor
- Nasser Aghdami MD., PhD
Solid Organ Transplant
Discharge to Home and Chronic Illness Care Pilot
The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered…
- Trial name
- NCT02165423
- Testing
- myFAMI iPad application
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Cytomegalovirus Infections, Heart Transplantation
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
- Trial name
- NCT01165580
- Testing
- valganciclovir [Valcyte]
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 17 people
- Sponsor
- Hoffmann-La Roche
Children Who Underwent Heart Transplantation Prior to Age 18, Received Care at Children's Healthcare of Atlanta
Allograft Fibrosis Following Pediatric Cardiac Transplantation
Transplantation is the preferred method of treating many forms of end-stage organ failure. While short-term results have improved, long-term outcomes remain inadequate.
- Trial name
- NCT00328185
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Children's Healthcare of Atlanta
Heart Transplant, Pediatric Heart Transplant
Non-invasive Prediction of EArly Cardiac rEjection
Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently…
- Conditions
- Heart Transplant, Pediatric Heart Transplant, Rejection, Cardiac MRI
- Trial name
- PEACE (NCT07770659)
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Vanderbilt University Medical Center
Cardiac Transplant, Patent Ductus Arterious
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis…
- Conditions
- Cardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis
- Trial name
- NCT00480740
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Children's National Research Institute
Nonadherence, Tacrolimus
Improving Medication-taking After Liver Transplant
The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.
- Conditions
- Nonadherence, Tacrolimus, Pediatric Liver Transplant Recipients
- Trial name
- I-AM (NCT01960322)
- Testing
- Telemetric
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Transplant Coronary Artery Disease
Coronary Artery Study in Pediatric Heart Transplantation
Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT).
- Trial name
- CAS-POHT (NCT01546870)
- Where
- United States
- Sponsor
- Arkansas Children's Hospital Research Institute