Study of Organ Perfusion in Heart Transplantation in Children

Heart Transplantation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06032195
• Other study ID #: CL-N-HTX-Paed-II/10/20
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Dr. F. Köhler Chemie GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Hours to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Drug:
• Custodiol-N
heart will preserved in and will be treated with Custodiol-N solution
• Custodiol
heart will preserved in and will be treated with Custodiol solution

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum der Charité	Berlin
Germany	Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie	Gießen
Germany	Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik	München

Sponsors (1)

Lead Sponsor	Collaborator
Dr. F. Köhler Chemie GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse event reporting	Safety assessment	up to 3 months
Secondary	heart rate	vital parameters	up to day 7 after release of the aortic cross clamp
Secondary	blood pressure (systolic (SBP) and diastolic (DBP))	vital parameters	up to day 7 after release of the aortic cross clamp
Secondary	body temperature	vital parameters	up to day 7 after release of the aortic cross clamp
Secondary	concentration of cardiac troponin	laboratory tests	up to day 7 after release of the aortic cross clamp
Secondary	concentration of creatinine kinase (CK-MB)	laboratory tests	up to day 7 after release of the aortic cross clamp
Secondary	(SBP (systolic blood pressure), DBP (diastolic blood pressure))	Haemodynamics	from termination of cardiopulmonary bypass until transfer to intensive care unit
Secondary	Heart Rhythm (HR)	Haemodynamics	from termination of cardiopulmonary bypass until transfer to intensive care unit
Secondary	Pulmonary artery pressure (PAP (if available))	Haemodynamics	from termination of cardiopulmonary bypass until transfer to intensive care unit
Secondary	Cerebrovascular resistance (CVR (if available))	Haemodynamics	from termination of cardiopulmonary bypass until transfer to intensive care unit
Secondary	Death	survival	up to 12 months
Secondary	function of transplanted organ (heart)	Graft survival	up to 3 months
Secondary	Readmission to intensive care unit (ICU)	return to intensive care unit	up to 3 months
Secondary	Length of ICU stays	duration of stay in intensive care unit	up to 3 months
Secondary	Catecholamine requirement	(yes/no)	up to day 7
Secondary	Antihypertensives intake	(yes/no)	up to 12 months
Secondary	Milrinone support	(yes/no)	up to day 7
Secondary	Need for pacemaker therapy	(yes/no)	up to day 7
Secondary	Left and right ventricular assist device (LVAD, RVAD)	Device therapy (each yes/no)	up to 3 months
Secondary	Extracorporeal membrane oxygenation (ECMO)	Device therapy (each yes/no)	up to 3 months
Secondary	Biventricular assist Device (BIVAD) or percutaneous LVAD	Device therapy (each yes/no)	up to 3 months
Secondary	Ejection fraction	Echocardiographic markers of function and rejection	up to day 7
Secondary	enddiastolic and endsystolic ventricle	Echocardiographic markers of function and rejection	up to day 7
Secondary	Cardiac arrhythmias	occurrence, severity, type	up to day 7