Brief Title
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
Official Title
The Role of Myocardial Fibrosis in Patients With Aortic Stenosis
Brief Summary
Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis. In symptomatic individuals, valve replacement is often the only effective treatment. However, there are no good markers to identify patients who may benefit from early surgery before symptoms developed. The purpose of the study is to test the hypothesis that the presence heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome in patients with aortic stenosis, and thus may be helpful in identifying patients for early valve replacement.
Detailed Description
Congestive heart failure and sudden cardiac death are associated complications of aortic stenosis. Currently, the indications for valvular replacement are based on the valvular severity evaluated by echocardiography and the presence of symptoms. There is some evidence to suggest the presence of myocardial fibrosis is associated with a poor outcome in patients with aortic stenosis. The aim of this prospective study is to investigate the prognostic implications of myocardial fibrosis in patients with aortic stenosis. The presence of myocardial fibrosis will be identified by delayed enhancement with the cardiac magnetic resonance imaging at 3T. We will also be evaluating the application of T1 mapping techniques to detect diffuse myocardial fibrosis.
Study Type
Observational
Primary Outcome
Cardiovascular events
Condition
Aortic Stenosis
Intervention
Cardiac Magnetic Resonance Imaging
Study Arms / Comparison Groups
Controls
Description: Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
203
Start Date
January 2012
Completion Date
August 2017
Primary Completion Date
January 2016
Eligibility Criteria
Inclusion Criteria: - Patients with aortic stenosis - Willing to undergo all investigations Exclusion Criteria: - Coexisting mitral valvular heart disease and aortic regurgitation (more than moderate severity) - Active medical conditions: ongoing heart failure, infection - Significant comorbidities: advanced malignancy with limited life expectancy - Unable to give informed consent - Contraindication for cardiac magnetic resonance imaging: impaired renal function, pacemaker, claustrophobia
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
David E Newby, MD PhD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01755936
Organization ID
2010/R/CAR/05
Responsible Party
Sponsor
Study Sponsor
University of Edinburgh
Collaborators
British Heart Foundation
Study Sponsor
David E Newby, MD PhD, Principal Investigator, University of Edinburgh
Verification Date
July 2016