Informations générales (source: ClinicalTrials.gov)
Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ? (DIAPASON)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
décembre 2012
janvier 2017
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Louis Pradel - Lyon - France | Hélène THIBAULT | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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)