Heart TransplantationPhase 2NCT06032195
Study of Organ Perfusion in Heart Transplantation in Children
A Phase 2 study testing Custodiol-N and Custodiol in people with Heart Transplantation, run by Dr. F. Köhler Chemie GmbH at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 24 hours to 17 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Custodiol-N and Custodiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesGermany
- Study dates
- 15 Aug 2023to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Failing Fontan patients
- Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
- Pregnancy and lactation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Deutsches Herzzentrum der Charité
Berlin, 13353
Christoph Knosalla, Prof. Dr., +49 30 4593-2102, christoph.knosalla@dhzc-charite.de
Joachim Photiadis, Prof. Dr., joachim.photiadis@dhzc-charite.de
- Recruiting
Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
Giessen, 35385
Mohamed Salem, Dr. med., +49 641 985-56314, Mohamed.Salem@chiru.med.uni-giessen.de
- Recruiting
Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
München, 81377
Christine-Elena Kamla, Dr. med., Christine.Kamla@med.uni-muenchen.de
Sebastian Michel, Dr. med., sebastian.michel@med.uni-muenchen.de
About this study
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
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.
Read the 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 .
- Conditions
- Heart Transplantation
- Being tested
- Custodiol-N, Custodiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custodiol-NDrug
Also called Solution for organ preservation in transplantation
heart will preserved in and will be treated with Custodiol-N solution
CustodiolDrug
Also called Solution for organ preservation in transplantation
heart will preserved in and will be treated with Custodiol solution
| Study group | Role | What they receive |
|---|---|---|
| Custodiol-N | Experimental | organ will be perfused with Custodiol-N solution Receives: Drug: Custodiol-N |
| Custodiol | Active comparator | organ will be perfused with Custodiol solution Receives: Drug: Custodiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event reporting
Safety assessment
Measured: up to 3 months
Secondary outcomes (23)
heart rate
vital parameters
Measured: up to day 7 after release of the aortic cross clamp
blood pressure (systolic (SBP) and diastolic (DBP))
vital parameters
Measured: up to day 7 after release of the aortic cross clamp
body temperature
vital parameters
Measured: up to day 7 after release of the aortic cross clamp
concentration of cardiac troponin
laboratory tests
Measured: up to day 7 after release of the aortic cross clamp
concentration of creatinine kinase (CK-MB)
laboratory tests
Measured: up to day 7 after release of the aortic cross clamp
(SBP (systolic blood pressure), DBP (diastolic blood pressure))
Haemodynamics
Measured: from termination of cardiopulmonary bypass until transfer to intensive care unit
Heart Rhythm (HR)
Haemodynamics
Measured: from termination of cardiopulmonary bypass until transfer to intensive care unit
Pulmonary artery pressure (PAP (if available))
Haemodynamics
Measured: from termination of cardiopulmonary bypass until transfer to intensive care unit
Cerebrovascular resistance (CVP (if available))
Haemodynamics
Measured: from termination of cardiopulmonary bypass until transfer to intensive care unit
Death
survival
Measured: up to 12 months
function of transplanted organ (heart)
Graft survival
Measured: up to 12 months
Readmission to intensive care unit (ICU)
return to intensive care unit
Measured: up to 12 months
Length of ICU stays
duration of stay in intensive care unit
Measured: up to 12 months
Catecholamine requirement
(yes/no)
Measured: up to day 7
Antihypertensives intake
(yes/no)
Measured: up to 12 months
Milrinone support
(yes/no)
Measured: up to day 7
Need for pacemaker therapy
(yes/no)
Measured: up to day 7
Left and right ventricular assist device (LVAD, RVAD)
Device therapy (each yes/no)
Measured: up to 12 months
Extracorporeal membrane oxygenation (ECMO)
Device therapy (each yes/no)
Measured: up to 12 months
Biventricular assist Device (BIVAD) or percutaneous LVAD
Device therapy (each yes/no)
Measured: up to 12 months
Ejection fraction
Echocardiographic markers of function and rejection
Measured: up to day 7
enddiastolic and endsystolic ventricle
Echocardiographic markers of function and rejection
Measured: up to day 7
Cardiac arrhythmias
occurrence, severity, type
Measured: up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 Aug 2023
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. F. Köhler Chemie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Knosalla, Prof. Dr., Principal investigator, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032195
- Sponsor's protocol ID
- CL-N-HTX-Paed-II/10/20
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06032195
- Acronym / sponsor ID
- CL-N-HTX-Paed-II/10/20
- Conditions
- Heart Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dr. F. Köhler Chemie GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custodiol-N | Experimental | Drug: Custodiol-Norgan will be perfused with Custodiol-N solution |
| Custodiol | Active comparator | Drug: Custodiolorgan will be perfused with Custodiol solution |
Who may qualify
- Ages
- 24 hours to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custodiol-NAlso: Solution for organ preservation in transplantationheart will preserved in and will be treated with Custodiol-N solution | Drug | Custodiol-N |
| CustodiolAlso: Solution for organ preservation in transplantationheart will preserved in and will be treated with Custodiol solution | Drug | Custodiol |
Primary outcome
adverse event reporting
Time frame: up to 3 months
Safety assessment
23 secondary outcomes
heart rate
Time frame: up to day 7 after release of the aortic cross clamp
blood pressure (systolic (SBP) and diastolic (DBP))
Time frame: up to day 7 after release of the aortic cross clamp
body temperature
Time frame: up to day 7 after release of the aortic cross clamp
concentration of cardiac troponin
Time frame: up to day 7 after release of the aortic cross clamp
concentration of creatinine kinase (CK-MB)
Time frame: up to day 7 after release of the aortic cross clamp
(SBP (systolic blood pressure), DBP (diastolic blood pressure))
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Heart Rhythm (HR)
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Pulmonary artery pressure (PAP (if available))
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Cerebrovascular resistance (CVP (if available))
Time frame: from termination of cardiopulmonary bypass until transfer to intensive care unit
Death
Time frame: up to 12 months
function of transplanted organ (heart)
Time frame: up to 12 months
Readmission to intensive care unit (ICU)
Time frame: up to 12 months
Length of ICU stays
Time frame: up to 12 months
Catecholamine requirement
Time frame: up to day 7
Antihypertensives intake
Time frame: up to 12 months
Milrinone support
Time frame: up to day 7
Need for pacemaker therapy
Time frame: up to day 7
Left and right ventricular assist device (LVAD, RVAD)
Time frame: up to 12 months
Extracorporeal membrane oxygenation (ECMO)
Time frame: up to 12 months
Biventricular assist Device (BIVAD) or percutaneous LVAD
Time frame: up to 12 months
Ejection fraction
Time frame: up to day 7
enddiastolic and endsystolic ventricle
Time frame: up to day 7
Cardiac arrhythmias
Time frame: up to day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Transplantation
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Knosalla, Prof. Dr. principal investigator
Deutsches Herzzentrum der Charité
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Custodiol-N and Custodiol in people with Heart Transplantation, run by Dr. F. Köhler Chemie GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roman Petrov, Dr. (+ 49-6251-1083 ext. -0, r.petrov@koehler-chemie.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse event reporting (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.