The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT01755936

Collaborator

British Heart Foundation (Other)

203

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis	Other: Cardiac Magnetic Resonance Imaging Other: Echocardiography Other: 72 hour Holter Monitor

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 Design

Study Type:

Observational

Actual Enrollment :

203 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Controls Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring	Other: Cardiac Magnetic Resonance Imaging For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated. Other: Echocardiography Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function. Other: 72 hour Holter Monitor This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis
Aortic Stenosis patients All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring	Other: Cardiac Magnetic Resonance Imaging For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated. Other: Echocardiography Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function. Other: 72 hour Holter Monitor This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

Arm

Intervention/Treatment

Controls

Patients will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring

Other: Cardiac Magnetic Resonance Imaging

For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated.

Other: Echocardiography

Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.

Other: 72 hour Holter Monitor

This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

Aortic Stenosis patients

All patients who agreed to study will undergo cardiac magnetic resonance imaging, echocardiography and 72 hour holter monitoring

Other: Cardiac Magnetic Resonance Imaging

Other: Echocardiography

Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.

Other: 72 hour Holter Monitor

This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis

Outcome Measures

Primary Outcome Measures

Cardiovascular events [1 year]
Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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