An observational study in Heart Failure and Coronary Artery Disease, sponsored by University of Luebeck. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-15.
Sponsored by University of Luebeck · Observational
Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging humoral markers for risk stratification in clinically stable heart failure patients and in patients with stable coronary artery disease. No data are available about the prognostic value of these peptides in relation to mortality and morbidity in patients undergoing cardiac surgery.
Primary objective of the present study is to test the hypothesis, that GDF-15 is superior to a standard preoperative risk score, the additive Euroscore for the prediction of 30 day mortality and postoperative morbidity in patients scheduled for cardiac surgery.
Secondary objectives are to test the predictive value of hsTNT, either alone, or in combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and preoperative cerebral oxygen saturation (ScO2) levels.
The study will be based on 2 patient cohorts, a group of patients studied during an observation period (2009) and a validation cohort of patients studied in 2008. The 2009 cohort (about 800 patients) will be analyzed to determine the predictive value of GDF-15 for predicting mortality and morbidity. The 2008 cohort (about 1200 patients) will be used to validate these findings.
Besides conventional morbidity markers, new sensitive markers of organ dysfunction (FABP, NGAL, sFLT-1, PIGF) will also be tested in the 2009 group.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 2,000 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients undergoing primary cardiac surgery at a University hospital.
Exclusion Criteria:
Patients undergoing cardiac surgery in 2009
Patients undergoing cardiac surgery in 2008
30 day mortality
The predictive accuracy of GDF-15 will be compared with the Euroscore. Since the Euroscore has been calibrated for 30 day mortality, this time frame will be used as primary outcome parameter.
Time frame: 30 days
1 year mortality
1 year mortality is a more relevant outcome variable than 30 day mortality
Time frame: 365 days
Renal dysfunction defined according to AKI-criteria
Renal dysfunction is an important outcome variable in cardiac surgery.
Time frame: 30 days
MaC score as combined measure of postoperative morbidity
The MACS is a combined score for postoperative complications: low cardiac output syndrome, need for renal replacement therapy, stroke, reintubation.
Time frame: 30 days
Sensitive markers of organ dysfunction
Fatty acid binding protein, neutrophyil gelatinase associated lipocalin are sensitive markers of organ dysfunction and shall be used to give more precise information on organ dysfunction.
Time frame: 4 days
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Luebeck