Coronary Artery DiseasePRACTICENCT04877795
Copeptin and HFABP in Cardiac Surgery
An observational study of Coronary Artery Disease and Valvular Heart Disease, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- Blood sampling
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 30 Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing elective on-pump cardiac surgery (i.e. CABG and/or valvular surgery).
Who may be able to join
- Adult (≥ 18 years of age)
- Elective surgery
- On-pump cardiac surgery (CABG and/or valvular surgery)
Who cannot join
- Heart transplantation (HTX)
- ACS at presentation (< 14 days)
- Emergency surgery
- Preoperative inotropic or mechanical circulatory support
- Left or right ventricular assist device implantation
- Unwilling or unable to provide consent
- Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heinrich-Heine-Universität
Düsseldorf, North Rhine-Westphalia, 40225
Sebastian Roth, MD, +492118118451, Sebastian.Roth@med.uni-duesseldorf.de
Giovanna Lurati Buse, MD, +492118117828, Giovanna.LuratiBuse@med.uni-duesseldorf.de
About this study
Official title: Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study
In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, >90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.
Read the detailed description
The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.
All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- Blood sampling
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Blood will be sampled from enrolled patients and analyzed for levels of troponin, copeptin and heart-type fatty acid binding protein (HFABP).
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery | Adult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery) Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability-free survival
Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guidelines.
Measured: 1 years after surgery
Secondary outcomes (5)
Days alive and out of hospital
Patient-centered outcome to measure morbidity and mortality after surgery
Measured: At 30 days and 12 months after surgery
Major adverse cardiovascular events (MACE)
Defined as non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure or transfer to a higher unit of care, atrial fibrillation or stroke
Measured: At 30 days and 12 months after surgery
All cause mortality
Evaluate mortality after cardiac surgery
Measured: At 30 days and 12 months after surgery
Length of ICU-stay
To observe the length and/or readmission rate of intensive care unit stay
Measured: At 30 days
Acute kidney injury (AKI)
As defined by the three-stage KDIGO (Kidney Disease: Improving Global Outcome) classification of severity
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877795
- Sponsor's protocol ID
- V1.0
- Acronym
- PRACTICE
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be entered into a secure on-line database documenting the time and individual entering the data. Data will be collected directly from source documents into the eCRF. A copy of the original source documents will be stored within a locked cabinet/office accessible to authorized personnel only. An identifiable patient data page reporting the assigned patient identification code will be stored separately also in a locked cabinet/office (accessible to authorized personnel only) in order to record in-hospital outcomes, conduct follow-up, supply missing data points, and to allow potential monitoring visits by regulatory authorities. All collected data will be archived for a period of 15 years. The secure database run by the clinical trials unit of the University Hospital Duesseldorf allows for data entry accountability and high security standards.
Publications
Kirkopoulos A, Salehi I, M'Pembele R, Maddison P, Stroda A, Tenge T, Donaldson D, Huhn R, Kindgen-Milles D, Haddad A, Brands J, Dubler S, Brenner T, Berger MM, Lurati Buse G, Roth S. Predictive value of early postoperative copeptin after cardiac surgery: A two-centre prospective cohort study. Eur J Anaesthesiol. 2025 Nov 1;42(11):1017-1024. doi: 10.1097/EJA.0000000000002251. Epub 2025 Aug 1.
PubMed 40755220
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04877795
- Acronym / sponsor ID
- PRACTICE / V1.0
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 May 2021 (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.
In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, >90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.
Detailed description
The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.
All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery | – | Diagnostic Test: Blood samplingAdult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective on-pump cardiac surgery (i.e. CABG and/or valvular surgery).
Key inclusion criteria (3 listed)
- Adult (≥ 18 years of age)
- Elective surgery
- On-pump cardiac surgery (CABG and/or valvular surgery)
Key exclusion criteria (7 listed)
- Heart transplantation (HTX)
- ACS at presentation (< 14 days)
- Emergency surgery
- Preoperative inotropic or mechanical circulatory support
- Left or right ventricular assist device implantation
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 |
|---|---|---|
| Blood samplingBlood will be sampled from enrolled patients and analyzed for levels of troponin, copeptin and heart-type fatty acid binding protein (HFABP). | Diagnostic test | Cardiac Surgery |
Primary outcome
Disability-free survival
Time frame: 1 years after surgery
Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guidelines.
5 secondary outcomes
Days alive and out of hospital
Time frame: At 30 days and 12 months after surgery
Major adverse cardiovascular events (MACE)
Time frame: At 30 days and 12 months after surgery
All cause mortality
Time frame: At 30 days and 12 months after surgery
Length of ICU-stay
Time frame: At 30 days
Acute kidney injury (AKI)
Time frame: At 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 40755220Kirkopoulos A, Salehi I, M'Pembele R, Maddison P, Stroda A, Tenge T, Donaldson D, Huhn R, Kindgen-Milles D, Haddad A, Brands J, Dubler S, Brenner T, Berger MM, Lurati Buse G, Roth S. Predictive value of early postoperative copeptin after cardiac surgery: A two-centre prospective cohort study. Eur J Anaesthesiol. 2025 Nov 1;42(11):1017-1024. doi: 10.1097/EJA.0000000000002251. Epub 2025 Aug 1.
- Individual participant dataSharing planned: No. Data will be entered into a secure on-line database documenting the time and individual entering the data. Data will be collected directly from source documents into the eCRF. A copy of the original source documents will be stored within a locked cabinet/office accessible to authorized personnel only. An identifiable patient data page reporting the assigned patient identification code will be stored separately also in a locked cabinet/office (accessible to authorized personnel only) in order to record in-hospital outcomes, conduct follow-up, supply missing data points, and to allow potential monitoring visits by regulatory authorities. All collected data will be archived for a period of 15 years. The secure database run by the clinical trials unit of the University Hospital Duesseldorf allows for data entry accountability and high security standards.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Valvular Heart Disease, run by Heinrich-Heine University, Duesseldorf at 1 site 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Sebastian Roth, MD (+492118118451, Sebastian.Roth@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability-free survival (time frame: 1 years after surgery). 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 NCT04877795, which also lists 1 linked publication.
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 7 May 2021.