NCT01862237

Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.

Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 : 1. assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis, 2. 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, 3. 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.

Conditions

• Type II Diabetes

Interventions

Type	Name	Description
OTHER	Intervention	* blood collection * Completion of a pre-operative cardiac MRI. * Completion of a coronary angiography examination * Completion during the surgery d'une myocardial biopsy, * Aortic echocardiographic follow-up (including post-operative ultrasound and ultrasound at 1 year * Completion of a cardiac MRI 1 year after surgery.

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2013-05-24
• Last updated: 2014-08-29

Locations

1 site across 1 country: France