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Clinical Trials/NCT01755936
NCT01755936
Completed
Not Applicable

The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

University of Edinburgh1 site in 1 country203 target enrollmentJanuary 2012
ConditionsAortic Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Stenosis
Sponsor
University of Edinburgh
Enrollment
203
Locations
1
Primary Endpoint
Cardiovascular events
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
August 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Cardiovascular events

Time Frame: 1 year

Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.

Study Sites (1)

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