Study of Organ Perfusion in Heart Transplantation in Children

Status Active, not recruiting

Clinical Trial Summary

The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to <18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is: to compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol. Participants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.

Clinical Trial Description

Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in patients with end stage heart failure when other treatments have failed. The surgical procedures for orthotopic heart transplantation are essentially the same in adult and paediatric patients . Due to anatomical variants in congenital heart disease the procurement procedure may be modified with regard to the extent of the Vena cava superior and the great vessels. In implantation most frequently the bicaval technique is used but the biatrial technique which is leaving the back wall of both atria in situ may also be employed. A main difference between adult and paediatric heart transplantation (HTx) are the indications for transplantation: In adults the majority of patients undergo HTx as treatment of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other treatments have failed. Infants younger than one year of age congenital heart disease (CHD) is the most common diagnosis representing more than every second case followed by dilated cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery and in whom myocardial dysfunction develops later . ;

Study Design

Related Conditions & MeSH terms

Heart Transplantation

Clinical Trial Details

NCT number	NCT06032195
Study type	Interventional
Source	Dr. F. Köhler Chemie GmbH
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	August 15, 2023
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06035991` - First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System	N/A
Recruiting	`NCT01927614` - Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy	N/A
Recruiting	`NCT01705015` - Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement	N/A
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2
Completed	`NCT01028599` - Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients	N/A
Completed	`NCT00531921` - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival	N/A
Terminated	`NCT00420537` - Shift to Everolimus (RAD) Kidney Sparing Study	Phase 4
Enrolling by invitation	`NCT03292861` - The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients	Phase 2
Recruiting	`NCT04924491` - Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children	Phase 1/Phase 2
Recruiting	`NCT05270902` - Haemoadsorption During Heart Transplantation	N/A
Completed	`NCT05289180` - Brachial Right Ventricle - Endomyocardial Biopsy
Recruiting	`NCT03687723` - Observational Study of the Clinical Use of the OCS™ Heart
Completed	`NCT01091194` - Effect of Exercise After Heart Transplantation	Phase 2
Completed	`NCT01182571` - Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients	N/A
Terminated	`NCT00678002` - Quality of Life in Pediatric Transplant Patients
Withdrawn	`NCT00780377` - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients	N/A
Withdrawn	`NCT00780637` - Brachial Artery t-PA Release in Heart Transplant Recipients	N/A
Withdrawn	`NCT00572286` - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study	N/A
Terminated	`NCT00121784` - Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients	Phase 4
Completed	`NCT00123331` - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.