Elective Valvular Cardiac SurgeryNCT02641665
Plasma Biomarkers in Cardiac Valve Surgery
An observational study of Elective Valvular Cardiac Surgery, run by University of Liege at 1 site in Belgium.
Trial summary
The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Valvular Cardiac Surgery
- What is being tested?
- Cardiac valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective or urgent cardiac valve surgery in isolation of in combination with CABG.
Who may be able to join
- Age ≥ 18 years
- Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG
Who cannot join
- Emergency or salvage surgery
- Inability to consent
- Previous cardiac surgery
- Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis
- Active Endocarditis
- Liver cirrhosis
- Chronic atrial fibrillation
- Pacemaker
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU of Liege
Liège, 4000
Gregory A Hans, MD, PhD, +3243667655, G.Hans@chu.ulg.ac.be
About this study
Official title: Measurement of Four Plasma Biomarkers for Risk Stratification and Determination of Functional Recovery After Cardiac Valve Surgery
The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).
- Conditions
- Elective Valvular Cardiac Surgery
- Being tested
- Cardiac valve surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac valve surgeryProcedure or surgery
Aortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s).
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary outcome
In hospital or 30-days mortality or inotropic support during more than 48 hours or lengthy of ICU stay longer than 5 days
Measured: 30 days
Secondary outcomes (7)
ICU readmission
Measured: 30 days
Post-operative AKI
AKIN stage during the first 48 hours
Measured: 48 hours
Ejection fraction
EF at 30 days and at 1 year
Measured: 1 year
NYHA
NYHA class at 30 days and at 1 year
Measured: 1 year
MLHFQ
Minnesota living with heart failure questionnaire at 30 days and at 1 year
Measured: 1 year
reshopitalisation
hospital admission for cardiac failure during the first postoperative year
Measured: 1 year
one year mortality
mortality during the first postoperative year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Valvular Cardiac SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641665
- Sponsor's protocol ID
- 2016001
- Status last verified
- Oct 2017
- First submitted
- 22 Dec 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Four Plasma Biomarkers for Risk Stratification and Determination of Functional Recovery After Cardiac Valve Surgery
- ClinicalTrials.gov ID
- NCT02641665
- Acronym / sponsor ID
- 2016001
- Conditions
- Elective Valvular Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2015 (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 level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective or urgent cardiac valve surgery in isolation of in combination with CABG.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG
Key exclusion criteria (8 listed)
- Emergency or salvage surgery
- Inability to consent
- Previous cardiac surgery
- Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis
- Active Endocarditis
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 |
|---|---|---|
| Cardiac valve surgeryAortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s). | Procedure or surgery | – |
Primary outcome
Composite primary outcome
Time frame: 30 days
In hospital or 30-days mortality or inotropic support during more than 48 hours or lengthy of ICU stay longer than 5 days
7 secondary outcomes
ICU readmission
Time frame: 30 days
Post-operative AKI
Time frame: 48 hours
Ejection fraction
Time frame: 1 year
NYHA
Time frame: 1 year
MLHFQ
Time frame: 1 year
reshopitalisation
Time frame: 1 year
one year mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: No
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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 Elective Valvular Cardiac Surgery, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 8 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 6 Oct 2017. 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 Belgium. 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 Gregory A Hans, MD, PhD (+3243667655, G.Hans@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary outcome (time frame: 30 days). 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 6 Oct 2017.