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

Type II Diabetes Clinical Trial

— DIAPASON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01862237
• Other study ID #: 2011.699
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2013
• Last updated: August 28, 2014
• Start date: December 2012
• Est. completion date: January 2017

Study information

• Verified date: August 2014
• Source: Hospices Civils de Lyon
• Contact: Hélène THIBAULT
• Phone: 4 72 35 73 32
• Email: helene.thibault[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Diabetes Mellitus, Type 2
• Type II Diabetes
• Ventricular Remodeling

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Louis Pradel	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Mass measured by echocardiography		Primary outcome is assessed at one year 1 year after aortic valve replacement.	No
Secondary	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.	No
Secondary	Measurement of BNP (Brain Natriuretic Peptide).		1 year after aortic valve replacement.	No
Secondary	Echocardiographic parameters.	Left Ventricular Ejection Fraction, Systolic Longitudinal Strain, Systolic Circumferential Strain, Systolic Radial Strain, Diameters, wall thickness.	1 year after aortic valve replacement.	No
Secondary	Magnetic Resonance Imaging (MRI) parameters.	LV mass, volumes, ejection fraction, replacement fibrosis mass on delayed enhanced studies, and interstitial fibrosis quantification (T1 mapping studies).	1 year after aortic valve replacement.	No