Heart FailurePhase 3NCT02869022
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
A Phase 3 study testing Custodiol-N, Custodiol and organ perfusion for heart transplantation in people with Heart Failure, run by Dr. F. Köhler Chemie GmbH at 9 sites in 2 countries.
Trial summary
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Custodiol-N, Custodiol and organ perfusion for heart transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jul 2016to 2 Sep 2019
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Donor criteria:
- deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
- recipients awaiting their first transplant
- recipients ≥ 18 and >/= 65 years
- recipient's signed informed consent
- waiting list
Who cannot join
- Donor criteria:
- not applicable
- Patient criteria:
- recipients participating in another interventional study
- pregnant or lactating patients
- history/demonstration of HIV antibodies or AIDS
Show all 9Show fewer
- multiorgan transplantation
- transMedics pump
- the explantation team is affiliated another clinic than transplantation team
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin
Berlin, 13353
Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen
Freiburg im Breisgau, 79106
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
Hamburg, 20246
Abt. Herzchirugie, Universitätsklinikum Heidelberg
Heidelberg, 69120
Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
Jena, 07747
Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg
Regensburg, 93042
Austria1 site
Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien
Vienna, 1090
About this study
Official title: A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
- Conditions
- Heart Failure
- Being tested
- Custodiol-N, Custodiol, organ perfusion for heart transplantation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custodiol-NDrug
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
CustodiolDrug
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
organ perfusion for heart transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Custodiol-N | Experimental | comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation Receives: Drug: Custodiol-N; Procedure: organ perfusion for heart transplantation |
| Custodiol | Active comparator | comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation Receives: Drug: Custodiol; Procedure: organ perfusion for heart transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatine kinase Myocard type "CK-MB" peak value
day 1: measurements 4, 8, 12, 16, 20, 24 hours ± 30 min; day 2-3: measurements 8, 16 and 24 hours ± 2 hours; day 4-7 one time/day
Measured: from 4 to 168 hours after release of the aortic cross clamp
Secondary outcomes (3)
Catecholamine requirement
defined as "yes" or "no"
Measured: from entry to the trial up to day 7
Patient survival
Measured: at 7 days and 1, 3 and 12 months
Complications
occurrence, severity, type, and duration
Measured: from the time of the transplantation 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 posted16 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. F. Köhler Chemie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabor Szabo, Prof. Dr., Principal investigator, Abt. Herzchirugie, Universitätsklinikum Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869022
- Sponsor's protocol ID
- CL-N-HTX-CSM-III/04/12
- Other IDs
- 2012-001112-29
- Status last verified
- Jan 2020
- First submitted
- 11 Aug 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
- ClinicalTrials.gov ID
- NCT02869022
- Acronym / sponsor ID
- CL-N-HTX-CSM-III/04/12
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Dr. F. Köhler Chemie GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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 objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
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-N, Procedure: organ perfusion for heart transplantationcomparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation |
| Custodiol | Active comparator | Drug: Custodiol, Procedure: organ perfusion for heart transplantationcomparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
- recipients awaiting their first transplant
- recipients ≥ 18 and >/= 65 years
- recipient's signed informed consent
- waiting list
Key exclusion criteria (9 listed)
- not applicable
- recipients participating in another interventional study
- pregnant or lactating patients
- history/demonstration of HIV antibodies or AIDS
- multiorgan transplantation
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-Ncomparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation | Drug | Custodiol-N |
| Custodiolcomparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation | Drug | Custodiol |
| organ perfusion for heart transplantation | Procedure or surgery | Custodiol, Custodiol-N |
Primary outcome
Creatine kinase Myocard type "CK-MB" peak value
Time frame: from 4 to 168 hours after release of the aortic cross clamp
day 1: measurements 4, 8, 12, 16, 20, 24 hours ± 30 min; day 2-3: measurements 8, 16 and 24 hours ± 2 hours; day 4-7 one time/day
3 secondary outcomes
Catecholamine requirement
Time frame: from entry to the trial up to day 7
Patient survival
Time frame: at 7 days and 1, 3 and 12 months
Complications
Time frame: from the time of the transplantation up to day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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. This study is not recruiting at the moment.
Gabor Szabo, Prof. Dr. principal investigator
Abt. Herzchirugie, Universitätsklinikum Heidelberg
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Custodiol-N, Custodiol and organ perfusion for heart transplantation in people with Heart Failure, run by Dr. F. Köhler Chemie GmbH at 9 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Creatine kinase Myocard type "CK-MB" peak value (time frame: from 4 to 168 hours after release of the aortic cross clamp). 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 18 Jan 2020.