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

Not Applicable

• Conditions: Type II Diabetes
• Interventions: Other: Intervention

• Registration Number: NCT01862237
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-24
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with type II diabetes	Intervention	Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.
Patients without type II diabetes	Intervention	No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.

Primary Outcome Measures

Name	Time	Method
Left Ventricular Mass measured by echocardiography	Primary outcome is assessed at one year 1 year after aortic valve replacement.

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI) parameters.	1 year after aortic valve replacement.	LV mass, volumes, ejection fraction, replacement fibrosis mass on delayed enhanced studies, and interstitial fibrosis quantification (T1 mapping studies).
Measurement of BNP (Brain Natriuretic Peptide).	1 year after aortic valve replacement.
Echocardiographic parameters.	1 year after aortic valve replacement.	Left Ventricular Ejection Fraction, Systolic Longitudinal Strain, Systolic Circumferential Strain, Systolic Radial Strain, Diameters, wall thickness.
cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test).	1 year after aortic valve replacement.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital Louis Pradel; 🇫🇷 Lyon, France