Clinical trials: Pediatric Cardiac Transplantation
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
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
Heart Failure, Transplant; Failure, Heart
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist…
- Conditions
- Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease
- Trial name
- NCT05610787
- Testing
- EXCOR Active Driving System for Pediatric VAD
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Berlin Heart, Inc
Cardiac Failure, Graft Rejection
Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs
This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to…
- Trial name
- OPTIMA (NCT06532890)
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- Northwestern University
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
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
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.
Pediatric ALL, Transplant; Failure, Heart
HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive…
- Trial name
- NCT05451979
- Testing
- MedBIKE HIIT
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- University of Alberta
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 Infection, Kidney Transplant Infection
CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients
CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a…
- Conditions
- Heart Transplant Infection, Kidney Transplant Infection, Liver Transplant Infection, CMV
- Trial name
- NCT03924219
- Testing
- CMV T cell Immunity Assay
- Where
- 12 sites in United States
- Volunteers
- 161 people
- Sponsor
- Vanderbilt University Medical Center
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
Pediatric ALL, Congenital Heart Disease
Virtual Remote Physiological Monitoring Program of Children With Heart Disease
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities.
- Conditions
- Pediatric ALL, Congenital Heart Disease, Single-ventricle, Biventricular Congestive Heart Failure
- Trial name
- NCT05034354
- Testing
- Remote physiological monitoring
- Where
- Canada
- Volunteers
- 23 people
- Sponsor
- University of Alberta
Pediatric Heart Transplant
Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients
Acute cardiac rejection is currently diagnosed by endomyocardial biopsy (EMB), but multiparametric cardiac magnetic resonance (CMR) may be a non-invasive alternative by its capacity for myocardial structure and function…
- Trial name
- NCT06795958
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Congenital Heart Disease, Advanced Heart Failure
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart…
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation
- Trial name
- TORCH-003 (NCT07837024)
- Testing
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
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
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
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
Dermatitis
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.
- Trial name
- NCT00176956
- Testing
- Skin Biopsy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hordinsky, Maria K., MD
Sinus Bradycardia, Atrioventricular Block
Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart
Heart transplants save the lives of nearly 500 children in heart failure per year. Columbia is one of the largest pediatric heart transplant centers in the world, averaging 25 transplants per year, and providing ongoing care to…
- Trial name
- NCT02462941
- Testing
- Adenosine, Cardiac catheterization
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Columbia University
RENAL INSUFFICIENCY, CHRONIC, LIVER FAILURE, ACUTE
Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant
A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant…
- Conditions
- RENAL INSUFFICIENCY, CHRONIC, LIVER FAILURE, ACUTE, HEART DISEASE
- Trial name
- ProQuad® (NCT02687763)
- Testing
- ProQuad
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Medical University of South Carolina