Clinical trial NCT06032195: Study of Organ Perfusion in Heart Transplantation in Children
Official title: A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Heart Transplantation
Lead sponsor: Dr. F. Köhler Chemie GmbH
Sponsor class: INDUSTRY
First posted: 2023-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 24
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 .

Eligibility criteria: Inclusion Criteria:

* Age from birth to less than18 years
* Recipients awaiting their first transplant
* Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
* written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
* Patient listed on the waiting list for heart transplantation

Exclusion Criteria:

* Patients who have participated within 30 days or are still participating in any other interventional studies
* history of severe organic disease other than concerning the heart
* history/demonstration of HIV antibodies or AIDS
* multiorgan transplantation
* machine-perfused organ
* the explantation team is affiliated to another clinic than transplantation team
* Failing Fontan patients
* Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
* Pregnancy and lactation

Primary outcomes:
measure: adverse event reporting
timeFrame: up to 3 months
Secondary outcomes:
measure: heart rate
timeFrame: up to day 7 after release of the aortic cross clamp
measure: blood pressure (systolic (SBP) and diastolic (DBP))
timeFrame: up to day 7 after release of the aortic cross clamp
measure: body temperature
timeFrame: up to day 7 after release of the aortic cross clamp
measure: concentration of cardiac troponin
timeFrame: up to day 7 after release of the aortic cross clamp
measure: concentration of creatinine kinase (CK-MB)
timeFrame: up to day 7 after release of the aortic cross clamp
measure: (SBP (systolic blood pressure), DBP (diastolic blood pressure))
timeFrame: from termination of cardiopulmonary bypass until transfer to intensive care unit
measure: Heart Rhythm (HR)
timeFrame: from termination of cardiopulmonary bypass until transfer to intensive care unit
measure: Pulmonary artery pressure (PAP (if available))
timeFrame: from termination of cardiopulmonary bypass until transfer to intensive care unit
measure: Cerebrovascular resistance (CVR (if available))
timeFrame: from termination of cardiopulmonary bypass until transfer to intensive care unit
measure: Death
timeFrame: up to 12 months
measure: function of transplanted organ (heart)
timeFrame: up to 3 months
measure: Readmission to intensive care unit (ICU)
timeFrame: up to 3 months
measure: Length of ICU stays
timeFrame: up to 3 months
measure: Catecholamine requirement
timeFrame: up to day 7
measure: Antihypertensives intake
timeFrame: up to 12 months
measure: Milrinone support
timeFrame: up to day 7
measure: Need for pacemaker therapy
timeFrame: up to day 7
measure: Left and right ventricular assist device (LVAD, RVAD)
timeFrame: up to 3 months
measure: Extracorporeal membrane oxygenation (ECMO)
timeFrame: up to 3 months
measure: Biventricular assist Device (BIVAD) or percutaneous LVAD
timeFrame: up to 3 months
measure: Ejection fraction
timeFrame: up to day 7
measure: enddiastolic and endsystolic ventricle
timeFrame: up to day 7
measure: Cardiac arrhythmias
timeFrame: up to day 7
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
city: München
country: Germany
facility: Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
Study officials:
affiliation: German Heart Institute
name: Christoph Knosalla, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: