Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery. (DIAPASON)
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.
The secondary objectives are :
- assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
- assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
- assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.
The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?|
- Left Ventricular Mass measured by echocardiography [ Time Frame: Primary outcome is assessed at one year 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
- cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test). [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
- Measurement of BNP (Brain Natriuretic Peptide). [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
- Echocardiographic parameters. [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]Left Ventricular Ejection Fraction, Systolic Longitudinal Strain, Systolic Circumferential Strain, Systolic Radial Strain, Diameters, wall thickness.
- Magnetic Resonance Imaging (MRI) parameters. [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]LV mass, volumes, ejection fraction, replacement fibrosis mass on delayed enhanced studies, and interstitial fibrosis quantification (T1 mapping studies).
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Patients with type II diabetes
Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.
Experimental: Patients without type II diabetes
No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862237
|Contact: Hélène THIBAULT||4 72 35 73 32 ext +firstname.lastname@example.org|
|Hospices Civils de Lyon - Hôpital Louis Pradel||Recruiting|
|Contact: Hélène THIBAULT 4 72 35 73 32 ext +33 email@example.com|
|Principal Investigator: Hélène THIBAULT|