ALANINE, ARGININE, DEFEROXAMINE, HISTIDINE, ASPARTIC ACID, GLYCINE, TRYPTOPHAN, SUCROSE, CALCIUM, MAGNESIUM, POTASSIUM, SODIUM, N-HYDROXY-3,4-DIMETHOXY-N-METHYL-BENZAMIDE, N-ACETYLHISTIDINE, CHLORIDE ION, OXOGLURIC ACID for Heart transplantation

Inclusion criteria

• {"criterion_text":"- Patient criteria: Age from birth to less than18 years"}
• {"criterion_text":"- Patient critera: Recipients awaiting their first transplant"}
• {"criterion_text":"- Patient criteria: Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial"}
• {"criterion_text":"- Patient criteria: written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)"}
• {"criterion_text":"- Patient criteria: Patient listed on the waiting list for heart transplantation"}
• {"criterion_text":"- Donor criteria: deceased donors should fulfil the standard criteria for organ donation (SCD)"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Safety assessment, i.e. continuous adverse event reporting up to 3 months","definition_or_measurement_approach":"Continuous adverse event reporting up to 3 months (safety assessment)."}

Secondary endpoints

• {"endpoint_text":"- Vital parameters (heart rate, blood pressure, body temperature) up to day 7","definition_or_measurement_approach":"Vital parameter measurements up to day 7 (heart rate, blood pressure, body temperature)."}
• {"endpoint_text":"- Laboratory tests including cardiac troponin and creatinine kinase (CK-MB) up to day 7o CK-MB peak value from 4 to 168 hours after release of the aortic cross clamp (measurements 4,8,12,16,20,24± 30min; 32h,40h,48h,56h,64h,72h ± 2 hours; visit 4-7 one time/interval) o CK-MB AUC value visit 1-7 o Troponin T up to 168 hours after release of the aortic cross clamp (measurements 4,8,12,16,20,24hours ± 30 min;32h,40h,48h,56h,64h,72h ± 2hours; visit 4-7 one time/interval) o Troponin AUC value visit 1-7","definition_or_measurement_approach":"Laboratory series with timed measurements (CK-MB and Troponin T) including peak values and AUC calculations from specified timepoints up to 168 hours post aortic cross clamp release."}
• {"endpoint_text":"- Hematology and clinical chemistry pre-operative and on visit 1,3,7 post-transplantation.","definition_or_measurement_approach":"Standard hematology and clinical chemistry panels measured pre-operatively and at visits 1, 3 and 7 post-transplant."}
• {"endpoint_text":"- Haemodynamics at termination of cardiopulmonary bypass, and after 4h, 8h and 12h after aortic cross clamp release but only until transfer to intensive care unit (SBP, DBP), HR, PAP (if available), CVR (if available)","definition_or_measurement_approach":"Hemodynamic measurements including SBP, DBP, HR, PAP and CVR at specified perioperative timepoints until ICU transfer."}
• {"endpoint_text":"- Death up to 3 months","definition_or_measurement_approach":"All-cause mortality assessed up to 3 months post-transplant."}
• {"endpoint_text":"- Graft survival up to 12 months","definition_or_measurement_approach":"Graft survival assessed up to 12 months."}
• {"endpoint_text":"- Readmission to ICU up to 12 months","definition_or_measurement_approach":"Occurrence of ICU readmission within 12 months."}
• {"endpoint_text":"- Length of ICU stays up to 12 months","definition_or_measurement_approach":"Duration of ICU stay measured (up to 12 months)."}
• {"endpoint_text":"- Catecholamine requirement (yes/no) up to day 7","definition_or_measurement_approach":"Binary assessment of catecholamine requirement through day 7."}
• {"endpoint_text":"- Antihypertensiva intake (yes/no) up to 3 months","definition_or_measurement_approach":"Binary assessment of antihypertensive medication intake up to 3 months."}
• {"endpoint_text":"- Milrinone support (yes/no) up to day 7","definition_or_measurement_approach":"Binary assessment of milrinone support use up to day 7."}
• {"endpoint_text":"- Need for pacemaker therapy (yes/no) up to day 7 and up to 12 months","definition_or_measurement_approach":"Binary assessment of pacemaker therapy requirement at specified time windows (day 7 and 12 months)."}
• {"endpoint_text":"- Device therapy (each yes/no) up to 12 months (including LVAD, RVAD,ECMO, BIVAD or percutaneuos LVAD)","definition_or_measurement_approach":"Binary assessment for each listed device therapy up to 12 months."}
• {"endpoint_text":"- Echocardiographic markers of function and rejection up to day 7 (Ejection fraction, enddiastolic and endsystolic ventricle volume)","definition_or_measurement_approach":"Echocardiographic measurements (EF, end-diastolic and end-systolic ventricular volumes) up to day 7."}
• {"endpoint_text":"- Cardiac arrhythmias up to day 7 (occurrence, severity, type)","definition_or_measurement_approach":"Assessment of occurrence, severity and type of cardiac arrhythmias up to day 7."}

Germany

Earliest CTIS Part Ii Submission Date

03-05-2024

Latest Decision Or Authorization Date

05-03-2025

Processing Time Days

306

Number Of Sites

3

Number Of Participants

15

Primary sponsor

Full Name

Dr. Franz Koehler Chemie GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"sponsorDuties codes: 1,10,12,5,6,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}