Plasma Biomarkers in Cardiac Valve Surgery

Elective Valvular Cardiac Surgery Clinical Trial

Official title:

Measurement of Four Plasma Biomarkers for Risk Stratification and Determination of Functional Recovery After Cardiac Valve Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02641665
• Other study ID #: 2016001
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2015
• Last updated: October 5, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: University Hospital of Liege
• Contact: Gregory A Hans, MD, PhD
• Phone: +3243667655
• Email: G.Hans[@]chu.ulg.ac.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Elective Valvular Cardiac Surgery

Intervention

Procedure:
• Cardiac valve surgery
Aortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s).

Locations

Country	Name	City	State
Belgium	CHU of Liege	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	ICU readmission		30 days
Secondary	Post-operative AKI	AKIN stage during the first 48 hours	48 hours
Secondary	Ejection fraction	EF at 30 days and at 1 year	1 year
Secondary	NYHA	NYHA class at 30 days and at 1 year	1 year
Secondary	MLHFQ	Minnesota living with heart failure questionnaire at 30 days and at 1 year	1 year
Secondary	reshopitalisation	hospital admission for cardiac failure during the first postoperative year	1 year
Secondary	one year mortality	mortality during the first postoperative year.	1 year