Clinical trial NCT01862237: Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
Official title: Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type II Diabetes
Keywords: Type II diabetes
aortic valve stenosis
left ventricular remodeling
aortic valve replacement surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Left Ventricular Mass measured by echocardiography
timeFrame: Primary outcome is assessed at one year 1 year after aortic valve replacement.
Secondary outcomes:
measure: cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test).
timeFrame: 1 year after aortic valve replacement.
measure: Measurement of BNP (Brain Natriuretic Peptide).
timeFrame: 1 year after aortic valve replacement.
measure: Echocardiographic parameters.
timeFrame: 1 year after aortic valve replacement.
measure: Magnetic Resonance Imaging (MRI) parameters.
timeFrame: 1 year after aortic valve replacement.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Louis Pradel
Study officials:
References: