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Congenital Heart MalformationsPhase 2NCT07381530

Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children

A Phase 2 study testing heart will be treated with Custodiol-N and heart will be treated with Custodiol in people with Congenital Heart Malformations, run by Dr. F. Köhler Chemie GmbH at 3 sites in Germany.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0) Read more about this study

Who is it for?
Ages 24 hours to 17 years
Conditions the study is for
Congenital Heart Malformations
What is being tested?
heart will be treated with Custodiol-N and heart will be treated with Custodiol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesGermany
Study dates
5 Dec 2024to Dec 2027
Phase
Phase 2
Are there results?
None posted in the registry

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 than 18 years of age
  • congenital heart surgery with cardiopulmonary bypass and cardioplegia
  • written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
  • Ability of the legal guardians to understand character and individual consequences of the clinical trial

Who cannot join

  • Patients who have participated within 30 days or are still participating in any other interventional study
  • History of severe organic (e.g. liver or kidney) disease other than concerning the heart
  • History of psychiatric disease
  • Pregnancy and lactation

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Universitätsklinikum Gießen und Marburg GmbH, Abteilung für Kinderherzchirurgie und angeborene Herzfehler

    Giessen, 35385

  • Deutsches Herzzentrum München, TUM Universitätsklinikum, Klinik für Chirurgie angeborener Herzfehler und Kinderherzchirurgie

    München, 80636

  • Universitätsklinikum Münster, Klinik für Herz- und Thoraxchirurgie,Sektion Kinderherzchirurgie

    Münster, 48149

Other trials in Germany

About this study

Official title: A Prospective Randomized, Single-blind, Multicenter Phase II Study Comparing Two Methods of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children: Custodiol-N Versus Custodiol

The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)

Read the detailed description

Efficacy of Custodiol-N and its safety is being thoroughly studied in adults undergoing solid organ transplantation. In addition, safety data are available from its use as cardioplegic solution in approximately 400 adults. Paediatric cardiac surgery nearly exclusively addresses congenital heart disease (CHD). CHD comprises a wide variety of congenital malformations of structures of the heart or the great vessels. The causes may be genetic, environmental or both. The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.

Being tested
heart will be treated with Custodiol-N, heart will be treated with Custodiol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • heart will be treated with Custodiol-NDrug

    cardioplegia solution will be administered with perfusion

  • heart will be treated with CustodiolDrug

    cardioplegia solution will be administered with perfusion

Study groups in NCT07381530
Study groupRoleWhat they receive
Custodiol-NExperimentalorgan will be perfused with Custodiol-N solution
Receives: Drug: heart will be treated with Custodiol-N
CustodiolActive comparatororgan will be perfused with Custodiol solution
Receives: Drug: heart will be treated with Custodiol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety assessment

    Continuous adverse events (AEs) reporting

    Measured: AEs up to 30 days postoperatively

  2. safety assessment

    Myocardial protection in surviving patients assessed by quantification of perioperative CK-MB levels (U/l)

    Measured: CK-MB (Creatinkinase-MB) levels at baseline until postoperative day 2 and postoperative day 7 or discharge

Secondary outcomes (26)

  1. Description of hemodynamics

    Vital signs (blood pressure (mmHg))

    Measured: day 7 postoperatively

  2. Description of hemodynamics

    Vital signs (heart rate (bpm))

    Measured: day 7 postoperatively

  3. Description of hemodynamics

    Vital signs (body temperature (°C))

    Measured: day 7 postoperatively

  4. Description of hemodynamics

    Vasopressor/ Catecholamine/ Vasodilator (incl. Milrinone)/ Levosimendan intake (yes/no by timepoint and amount (μg/kg/min))

    Measured: day 7 postoperatively

  5. Description of hemodynamics

    Nitric oxide ventilation (yes/no by timepoint)

    Measured: day 7 postoperatively

  6. Description of hemodynamics

    Extracorporeal membrane oxygenation (ECMO) support (yes/no by timepoint)

    Measured: day 7 postoperatively

  7. Description of hemodynamics

    Need for placement of a permanent Medical Circulatory Support (MCS) (left ventricular assist device (LVAD), right ventricular assist device (RVAD), biventricular assist support (BiVAD)), (yes/no by timepoint)

    Measured: 30 days postoperatively

  8. Description of hemodynamics

    Need for heart transplant (yes/no by timepoint)

    Measured: 30 days postoperatively

  9. Description of echo

    Systemic-ventricular function (good, moderately impaired, severely impaired)

    Measured: Baseline, after skin closure and day 7 postoperatively

  10. Description of cardiac injury

    Creatine kinase (CK (U/l))

    Measured: at baseline until postoperative day 2 and postoperative day 7 or discharge

  11. Description of cardiac injury

    Troponin T (ng/ml)

    Measured: at baseline until postoperative day 2 and postoperative day 7 or discharge

  12. Description of hospitals stay/ death

    Death (date)

    Measured: 30 days postoperatively

  13. Description of hospitals stay/ death

    readmission (to hospital or intensive care), (yes/no and number)

    Measured: 30 days postoperatively

  14. Description of hospitals stay/ death

    Length of ICU stay (start and end date)

    Measured: 30 days postoperatively

  15. Description of hospitals stay/ death

    Length of hospital stay (start and end date)

    Measured: 30 days postoperatively

  16. Description of surgery

    Aortic cross clamping time (min)

    Measured: during surgery

  17. Description of surgery

    Incision-to-closure-time (min)

    Measured: during surgery

  18. Description of surgery

    Reperfusion time (min)

    Measured: during surgery

  19. Description of surgery

    Number of intraoperative administrations of cardioplegia

    Measured: during surgery

  20. Description of surgery

    Total administration duration (min)

    Measured: during surgery

  21. Description of surgery

    Total administration amount (ml)

    Measured: during surgery

  22. Description of 12-Lead-ECG

    Shift in 12-Lead-ECG (ECG QT Interval)

    Measured: baseline and day 1 postoperatively (Intensive Care Unit)

  23. Description of cardiac arrhythmias

    Current heart rhythm (Sinus rhythm, atrioventricular block (AV-Block °I), AV-Block °II, AV-Block °III, Ectopic atrial rhythm with intact AV conduction, other tachycardiac arrhythmia)

    Measured: until day 7 postoperatively

  24. Description of cardiac arrhythmias

    Tachyarrhythmic event since last visit (JET/atrial fibrillation/atrial flutter/ ventricular arrhythmia)

    Measured: until day 7 postoperatively

  25. Description of cardiac arrhythmias

    Need for antiarrhythmic therapy other than beta blockers after end of aortic cross-clamping since last visit (e.g. Adenosine, Amiodarone, Flecainid), (yes/no)

    Measured: until day 7 postoperatively

  26. Description of cardiac arrhythmias

    Current cardiac pacing (none/atrial/ventricular/sequential)

    Measured: 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start5 Dec 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Why it stopped: Sponsor Decision

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381530
Sponsor's protocol ID
CL-N-CP-Paed-II/09/19
Status last verified
Feb 2026
First submitted
28 Oct 2024
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing heart will be treated with Custodiol-N and heart will be treated with Custodiol in people with Congenital Heart Malformations, 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 4 inclusion and 4 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: paused, as of the sponsor's last update on 9 Feb 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety assessment (time frame: AEs up to 30 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381530.

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 9 Feb 2026.

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