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

Civil Hospices of Lyon

Status: Unknown

Conditions: Type II Diabetes

Treatments: Other: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01862237

2011.699

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

100 participants in 2 patient groups

Patients with type II diabetes

Experimental group

Description:

Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.

Treatment:

Other: Intervention

Patients without type II diabetes

Experimental group

Description:

No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.

Treatment:

Other: Intervention