Clinical trials: Pediatric Heart Transplantation
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
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
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
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
Semilunar Heart Valve Replacement
Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
The long-term goal of this research initiative is to develop a new valve replacement option for neonates, infants and young children.
- Trial name
- NCT05372757
- Testing
- Partial Heart Transplantation
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Medical University of South Carolina
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.
Heart-Assist Devices, Infections
Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants.
- Conditions
- Heart-Assist Devices, Infections, Heart Transplant Infection
- Trial name
- VADINFECT (NCT06464016)
- Testing
- Ventricular Assist Device with Berlin Heart EXCOR
- Where
- France
- Volunteers
- 47 people
- Sponsor
- Claude Bernard University
Congenital Disorders
A Retrospective Review - Anti-HLA Antibodies
Transplant rejection following organ transplant occurs because the recipient's immune system attacks the transplanted organ. The recipients immune system recognizes the transplanted organ as foreign tissue and attempts to destroy…
- Trial name
- NCT00460824
- Where
- United States
- Sponsor
- Emory University
Ventricular Dysfunction, Ventricular Dysfunction, Left
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric.
- Conditions
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
- Trial name
- NCT03701997
- Testing
- EXCOR Pediatric
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Berlin Heart, Inc
Heart Transplant Rejection, Immune Suppression
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR)…
- Conditions
- Heart Transplant Rejection, Immune Suppression, Pediatric Heart Transplant, Medication Nonadherence
- Trial name
- NCT05732779
- Testing
- DOT intervention
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of Florida
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
Pediatric Heart Transplant
Relationship Between EBV and PTLD
The purpose of this study is to determine the significance of an elevated quantitative EBV PCR and to determine the relationship between a EBV PCR value and the risk of developing PTLD.
- Trial name
- NCT00215033
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Children's Healthcare of Atlanta
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
Pediatric Heart Transplantation, Pediatric Heart Transplant Recipients
Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function
This is a multi-center, prospective, single cohort, observational study of pediatric heart transplant recipients designed to determine the impact of preformed versus de novo human leukocyte antigen (HLA) donor-specific antibodies…
- Trial name
- NCT02752789
- Where
- 9 sites in United States, Canada
- Volunteers
- 407 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
Pediatric Heart Transplantation, Pediatric Heart Transplant Recipients
Alloantibodies in Pediatric Heart Transplantation
The purpose of this study is to determine the clinical outcomes of sensitized pediatric heart transplant recipients with a positive donor-specific cytotoxicity crossmatch and to compare this group with outcomes in nonsensitized…
- Trial name
- NCT01005316
- Testing
- Induction Therapy, Tacrolimus, Mycophenolate Mofetil
- Where
- 8 sites in United States, Canada
- Volunteers
- 290 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Validate Volumetric Absorptive Microsampling (VAMS) Assay
Tacrolimus Microsampling
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study.
- Trial name
- VAMS (NCT04810143)
- Testing
- Mitra Microsampler
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Disorders
Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation
Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well.
- Trial name
- NCT00268047
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Healthcare of Atlanta
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
Congenital Abnormalities, Pulmonary Arterial Hypertension (PAH)
Safety and Effectiveness of a Virtual Pediatric Cardiac Rehabilitation Program or Telerehabilitation in Children With Heart Disease
Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service.
- Conditions
- Congenital Abnormalities, Pulmonary Arterial Hypertension (PAH), Orthotopic Heart Transplant, Cardiac Rehabilitation
- Trial name
- NCT06819059
- Testing
- Pediatric Cardiac Telerehabilitation, Fitness Tracker Only
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University