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Study of Organ Perfusion in Heart Transplantation in Children

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ClinicalTrials.gov Identifier: NCT06032195
Recruitment Status : Active, not recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Dr. F. Köhler Chemie GmbH

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: Custodiol-N Drug: Custodiol Phase 2

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 .

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
Primary Purpose: Treatment
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
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Custodiol-N
organ will be perfused with Custodiol-N solution
 Drug: Custodiol-N
heart will preserved in and will be treated with Custodiol-N solution
Other Name: Solution for organ preservation in transplantation
Active Comparator: Custodiol
organ will be perfused with Custodiol solution
 Drug: Custodiol
heart will preserved in and will be treated with Custodiol solution
Other Name: Solution for organ preservation in transplantation


Outcome Measures
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Primary Outcome Measures :
  1. adverse event reporting [ Time Frame: up to 3 months ]
    Safety assessment


Secondary Outcome Measures :
  1. heart rate [ Time Frame: up to day 7 after release of the aortic cross clamp ]
    vital parameters

  2. blood pressure (systolic (SBP) and diastolic (DBP)) [ Time Frame: up to day 7 after release of the aortic cross clamp ]
    vital parameters

  3. body temperature [ Time Frame: up to day 7 after release of the aortic cross clamp ]
    vital parameters

  4. concentration of cardiac troponin [ Time Frame: up to day 7 after release of the aortic cross clamp ]
    laboratory tests

  5. concentration of creatinine kinase (CK-MB) [ Time Frame: up to day 7 after release of the aortic cross clamp ]
    laboratory tests

  6. (SBP (systolic blood pressure), DBP (diastolic blood pressure)) [ Time Frame: from termination of cardiopulmonary bypass until transfer to intensive care unit ]
    Haemodynamics

  7. Heart Rhythm (HR) [ Time Frame: from termination of cardiopulmonary bypass until transfer to intensive care unit ]
    Haemodynamics

  8. Pulmonary artery pressure (PAP (if available)) [ Time Frame: from termination of cardiopulmonary bypass until transfer to intensive care unit ]
    Haemodynamics

  9. Cerebrovascular resistance (CVR (if available)) [ Time Frame: from termination of cardiopulmonary bypass until transfer to intensive care unit ]
    Haemodynamics

  10. Death [ Time Frame: up to 12 months ]
    survival

  11. function of transplanted organ (heart) [ Time Frame: up to 3 months ]
    Graft survival

  12. Readmission to intensive care unit (ICU) [ Time Frame: up to 3 months ]
    return to intensive care unit

  13. Length of ICU stays [ Time Frame: up to 3 months ]
    duration of stay in intensive care unit

  14. Catecholamine requirement [ Time Frame: up to day 7 ]
    (yes/no)

  15. Antihypertensives intake [ Time Frame: up to 12 months ]
    (yes/no)

  16. Milrinone support [ Time Frame: up to day 7 ]
    (yes/no)

  17. Need for pacemaker therapy [ Time Frame: up to day 7 ]
    (yes/no)

  18. Left and right ventricular assist device (LVAD, RVAD) [ Time Frame: up to 3 months ]
    Device therapy (each yes/no)

  19. Extracorporeal membrane oxygenation (ECMO) [ Time Frame: up to 3 months ]
    Device therapy (each yes/no)

  20. Biventricular assist Device (BIVAD) or percutaneous LVAD [ Time Frame: up to 3 months ]
    Device therapy (each yes/no)

  21. Ejection fraction [ Time Frame: up to day 7 ]
    Echocardiographic markers of function and rejection

  22. enddiastolic and endsystolic ventricle [ Time Frame: up to day 7 ]
    Echocardiographic markers of function and rejection

  23. Cardiac arrhythmias [ Time Frame: up to day 7 ]
    occurrence, severity, type


Eligibility Criteria
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Ages Eligible for Study:   24 Hours to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06032195


Locations
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Germany
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
Gießen, Germany, 35385
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
München, Germany, 81377
Sponsors and Collaborators
Dr. F. Köhler Chemie GmbH
Investigators
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Principal Investigator: Christoph Knosalla, Prof. Dr. German Heart Institute
More Information
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Responsible Party: Dr. F. Köhler Chemie GmbH
ClinicalTrials.gov Identifier: NCT06032195    
Other Study ID Numbers: CL-N-HTX-Paed-II/10/20
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions