Status:
UNKNOWN
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Type II Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes
- Aortic valve stenosis
- LVEF \> 50% with no kinetic abnormalities
- Non significant obstructive coronary artery disease
- Absence of gadolinium enhanced MRI contraindications
- Informed consent signed
- Patient affiliated to the French Social Security.
Exclusion
- Chronic arrhythmia or absence of sinus rhythm
- Past history of cardiomyopathy or coronary insufficiency
- Significant coronaropathy seen during the coronary angiography with \>50% degree stenosis prior to aortic valve replacement
- Hemodynamically significant valvular dysfunction other than aortic stenosis (grade 2 mitral or aortic insufficiency, mitral valve stenosis \< 1.5 cm2)
- Systemic chronic inflammatory disease leading to cardiac injury (scleroderma)
- Renal insufficiency (clearance \< 30 ml/min)
- Insufficient transthoracic echocardiography echogenicity
- Type I diabetes mellitus
- Uncontrolled hypertension (\> 180/100 mm Hg)
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01862237
Start Date
December 1 2012
End Date
January 1 2017
Last Update
August 29 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospices Civils de Lyon - Hôpital Louis Pradel
Lyon, France