Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
NCT ID: NCT01862237
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2012-12-31
2017-01-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Patients with type II diabetes
Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.
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.
Patients without type II diabetes
No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hospices Civils de Lyon - Hôpital Louis Pradel
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Hélène THIBAULT
Role: primary
References
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Cherpaz M, Meugnier E, Seillier G, Pozzi M, Pierrard R, Leboube S, Farhat F, Vola M, Obadia JF, Amaz C, Chalabreysse L, May C, Chanon S, Brun C, Givre L, Bidaux G, Mewton N, Derumeaux G, Bergerot C, Paillard M, Thibault H. Myocardial transcriptomic analysis of diabetic patients with aortic stenosis: key role for mitochondrial calcium signaling. Cardiovasc Diabetol. 2024 Jul 8;23(1):239. doi: 10.1186/s12933-024-02329-5.
Other Identifiers
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2011.699
Identifier Type: -
Identifier Source: org_study_id