Aortic Valve DiseasePhase 3Custodiol-AVNCT02098772
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
A Phase 3 study testing Custodiol-N and Custodiol in people with Aortic Valve Disease and Coronary Artery Disease (CAD), run by Dr. F. Köhler Chemie GmbH at 6 sites in Germany.
Trial summary
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Aortic Valve Disease, Coronary Artery Disease (CAD)
- What is being tested?
- Custodiol-N and Custodiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 6 sitesGermany
- Study dates
- May 2014to Dec 2018
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >/= 30 and </= 85 years of age
- Male or female with aortic valve disease
- Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
- Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.
Who cannot join
- History of recent (< 6 weeks) Q-wave myocardial infarction
- Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
- Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
- Pregnant or lactating patients
- Patients who have participated in any other investigational studies within 30 days previous to enrollment
- Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
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- Patients with severe chronic obstructive lung disease (FEV1 < 50%)
- Previous cardiac valvular disease (clinical relevant)
- GFR <60 ml/min
- Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale
- Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination
- History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Klinik für Thorax-, Herz- und Gefäßchirurgie, Uniklinik der RWTH Aachen
Aachen, 52074
Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
Hamburg, 20246
Klinik für Herzchirurgie, Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Klinik für Herz- und Thoraxchirurgie Universitätsklinikum Jena
Jena, Thuringia, 07747
Klinik für Herzchirurgie Universität Leipzig/ Herzzentrum Leipzig
Leipzig, Saxony, 04289
Klinik für Herz- und Gefäßchirurgie GmbH, Herz-Kreislauf-Zentrum Rotenburg
Rotenburg an der Fulda, Hesse, 36199
About this study
Official title: A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).
- Being tested
- Custodiol-N, Custodiol
- Keywords
- aortic valve disease, coronary bypass surgery, cardioplegic solutions
- Medical subject headings
- Aortic Valve Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custodiol-NDrug
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
CustodiolDrug
comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
| Study group | Role | What they receive |
|---|---|---|
| Custodiol-N | Experimental | comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery Receives: Drug: Custodiol-N |
| Custodiol | Active comparator | comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery Receives: Drug: Custodiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak value for CK-MB
Measured: measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp
Secondary outcomes (1)
Catecholamine requirement on SICU
Measured: within 24 hours (cumulative dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion16 Nov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. F. Köhler Chemie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabor Szabó, Prof., Principal investigator, Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098772
- Sponsor's protocol ID
- CL-N-CSM-AV-III/05/12
- Acronym
- Custodiol-AV
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
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 Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
- ClinicalTrials.gov ID
- NCT02098772
- Acronym / sponsor ID
- Custodiol-AV / CL-N-CSM-AV-III/05/12
- Keywords
- aortic valve disease, coronary bypass surgery, cardioplegic solutions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Dr. F. Köhler Chemie GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Mar 2014 (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 compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custodiol-N | Experimental | Drug: Custodiol-Ncomparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery |
| Custodiol | Active comparator | Drug: Custodiolcomparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients >/= 30 and </= 85 years of age
- Male or female with aortic valve disease
- Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
- Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.
Key exclusion criteria (12 listed)
- History of recent (< 6 weeks) Q-wave myocardial infarction
- Left ventricular ejection fraction < 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
- Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
- Pregnant or lactating patients
- Patients who have participated in any other investigational studies within 30 days previous to enrollment
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 cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery | Drug | Custodiol-N |
| Custodiolcomparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery | Drug | Custodiol |
Primary outcome
peak value for CK-MB
Time frame: measured at 4, 8, 12, 16, 20 and 24 hours after the release of the aortic cross clamp
1 secondary outcome
Catecholamine requirement on SICU
Time frame: within 24 hours (cumulative dose)
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.
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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 Szabó, Prof. principal investigator
Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Custodiol-N and Custodiol in people with Aortic Valve Disease and Coronary Artery Disease (CAD), run by Dr. F. Köhler Chemie GmbH at 6 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 12 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 6 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 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?
peak value for CK-MB (time frame: measured at 4, 8, 12, 16, 20 and 24 hours after the 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.