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

NCT01862237 | Unknown

• 1 other identifier: 2011.699
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
2. 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. 3.assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.

Conditions

Type II Diabetes

Keywords

Type II diabetes; aortic valve stenosis; left ventricular remodeling; aortic valve replacement surgery

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Mass measured by echocardiography

  Primary outcome is assessed at one year 1 year after aortic valve replacement.

Secondary Outcomes (4)

• 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.

  1 year after aortic valve replacement.

• Magnetic Resonance Imaging (MRI) parameters.

  1 year after aortic valve replacement.

Study Arms (2)

Patients with type II diabetes

EXPERIMENTAL

Type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.

Other: Intervention

Patients without type II diabetes

EXPERIMENTAL

No type II diabetes patients with aortic valve stenosis referred for aortic valve replacement.

Other: Intervention

Interventions

Intervention OTHER

* 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 with type II diabetes; Patients without type II diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital Louis Pradel

Lyon, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 38978010 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Aortic Valve Stenosis; Ventricular Remodeling

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Hélène THIBAULT

CONTACT

4 72 35 73 32; helene.thibault@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 24, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

FR (1)