Comparing two solutions for heart transplantation in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial aims to evaluate the safety of Custodiol-N compared to its predecessor, Custodiol, in heart transplantation for children under 18 years old. The study is prospective, randomized, and single-blind, involving multiple centers. Participants will receive a heart perfused with either Custodiol-N or Custodiol, and researchers will assess the safety of the new solution. The trial focuses on children awaiting their first heart transplant, addressing the unique challenges of pediatric heart transplantation.

Why it matters

Who can join: the full rules

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

Where it's running

• Deutsches Herzzentrum der Charité
  Berlin, Germany Recruiting
• Universitätsklinikum Gießen (UKGM), Kinderherzzentrum, Klinikum für Kinderherzchirurgie
  Giessen, Germany Recruiting
• Klinikum der Universität München (LMU), Klinik und Poliklinik für Herzchirurgie, Chirurgische Klinik
  München, Germany Recruiting

Study contacts

• Principal investigator: Christoph Knosalla, Prof. Dr. — Deutsches Herzzentrum der Charité
• Study coordinator: Roman Petrov, Dr.
• Email: r.petrov@koehler-chemie.de
• Phone: + 49-6251-1083

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant

  This project tests whether a blood test measuring donor-derived cell-free DNA can help monitor rejection in adults who have had a heart transplant.

  Recruiting Karolinska Institutet · Stockholm · NCT07531784

• Metabolic deterioration after heart transplant determines outcomes

  We'll test whether worsening cardiac and systemic metabolism after a heart transplant predicts heart function and long-term survival in adult transplant recipients.

  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf, North Rhine-Westphalia · NCT07372820

• Mapping fat-cell sizes around the coronary arteries to trace inflammation

  This project will test whether differences in fat-cell size next to the coronary arteries can show how inflammation spreads in people having a heart transplant for advanced heart failure.

  Recruiting Institute for Clinical and Experimental Medicine · Prague · NCT07360925

• Multimodal analysis of heart biopsy samples

  This project will take one extra small heart biopsy during a clinically needed procedure to test whether detailed molecular and immune analyses can find disease-specific signatures in adults with cardiomyopathies, myocarditis, cardiac amyloidosis, or after heart transplant.

  Recruiting University Hospital, Essen · Essen, North Rhine-Westphalia · NCT07359690

• Long-term health of children born to mothers who had a solid organ transplant

  This project will look for long-term heart, kidney, and immune system problems in people aged 16 and older who were born to mothers who had a kidney, liver, pancreas, heart, or lung transplant.

  Recruiting University Medical Center Groningen · Groningen, Provincie Groningen · NCT07291258

• Cardiac rehabilitation cohort at Medicine Campus Davos to explore recovery

  This project will follow adults coming to Hochgebirgsklinik Davos for cardiac rehabilitation to see how their heart health and recovery progress over time.

  Recruiting Hochgebirgsklinik Davos · Davos, Kanton Graubünden · NCT07096973

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.