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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type II Diabetes
• Intervention / Treatment: Other: Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène THIBAULT; Phone Number: +33 4 72 35 73 32; Email: helene.thibault@chu-lyon.fr

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon - Hopital Louis Pradel
    • Contact: Hélène THIBAULT; Phone Number: +33 4 72 35 73 32; Email: helene.thibault@chu-lyon.fr
    • Principal Investigator: Hélène THIBAULT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with type II diabetes; Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.	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.
Experimental: Patients without type II diabetes; No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Measurement of BNP (Brain Natriuretic Peptide).		1 year after aortic valve replacement.
Echocardiographic parameters.	Left Ventricular Ejection Fraction, Systolic Longitudinal Strain, Systolic Circumferential Strain, Systolic Radial Strain, Diameters, wall thickness.	1 year after aortic valve replacement.
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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: aortic valve stenosis; left ventricular remodeling; Type II diabetes; aortic valve replacement surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Diabetes Mellitus; Diabetes Mellitus, Type 2; Aortic Valve Stenosis; Ventricular Remodeling
• Other Study ID Numbers: 2011.699