Trial record 8 of 220 for:    aortic valve replacement

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01862237
First received: May 22, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Type II Diabetes
Other: Intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Left Ventricular Mass measured by echocardiography [ Time Frame: Primary outcome is assessed at one year 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiovascular events (cardiac mortality, heart failure, atrial or ventricular rhythm abnormalities) and clinical improvement (NYHA class, 6-minute walk test). [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
  • Measurement of BNP (Brain Natriuretic Peptide). [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
  • Echocardiographic parameters. [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
    Left Ventricular Ejection Fraction, Systolic Longitudinal Strain, Systolic Circumferential Strain, Systolic Radial Strain, Diameters, wall thickness.

  • Magnetic Resonance Imaging (MRI) parameters. [ Time Frame: 1 year after aortic valve replacement. ] [ Designated as safety issue: No ]
    LV mass, volumes, ejection fraction, replacement fibrosis mass on delayed enhanced studies, and interstitial fibrosis quantification (T1 mapping studies).


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • BMI < 30 kg/m2
  • Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes
  • Aortic valve stenosis
  • LVEF > 55% 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 (> 160/100 mm Hg)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862237

Contacts
Contact: Hélène THIBAULT 4 72 35 73 32 ext +33 helene.thibault@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - Hôpital Louis Pradel Recruiting
Lyon, France
Contact: Hélène THIBAULT    4 72 35 73 32 ext +33    helene.thibault@chu-lyon.fr   
Principal Investigator: Hélène THIBAULT         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01862237     History of Changes
Other Study ID Numbers: 2011.699
Study First Received: May 22, 2013
Last Updated: April 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Type II diabetes
aortic valve stenosis
left ventricular remodeling
aortic valve replacement surgery

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 26, 2014